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The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.
The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| desflurane | Experimental |
| |
| desflurane/N2O | Experimental |
| |
| sevoflurane/N2O | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desflurane | Drug | volatile liquid for inhalation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Body Movement During Anesthetic Maintenance | The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants With Recall/Memory Issues During Anesthetic Maintenance | The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance | Rescue medication includes vasopressors and depressors. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% | "Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to <150 mmHg and heart rate 50 to <100 bpm could be maintained " | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% | Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Awakening | Time from the end of study drug inhalation. After the end of inhalation of the study drug, the investigator commanded the patient to open his/her eyes once every minute to check whether he/she awoke and recorded the time of awakening. | Day 1 (Post-Surgery, from the end of study drug inhalation to awakening) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junzo Takeda, MD | School of Medicine, Keio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagoshima University Medical and Dental University | Kagoshima | Japan | ||||
| Kyoto University |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLM 240 N2O Group | Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| FG001 | BLM 240 O2 Group | Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| FG002 | Sevoflurane Group | Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BLM 240 N2O Group | Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| BG001 | BLM 240 O2 Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Body Movement During Anesthetic Maintenance | The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance. | Full Analysis Set (FAS) - subjects assigned to treatment groups, excluding subjects with significant GCP violations (significant violations regarding informed consent and study procedures), subjects who did not receive the allocated study drug, subjects whose ASA status was not Class I, II, III, or subjects for whom no data were available. | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
3 Days before study drug through 7 days after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BLM 240 Group | 0 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered state of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baxter Clinical Trial Disclosures Call Center | Baxter Healthcare | (224)948-7359 | Global_CORP_ClinicalTrialsDisclosure@baxter.com |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D009609 | Nitrous Oxide |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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| desflurane/nitrous oxide | Drug | volatile liquid for inhalation with gas for inhalation |
|
|
| sevoflurane/nitrous oxide | Drug | volatile liquid for inhalation and gas for inhalation |
|
|
| Overall Assessment of Efficacy | Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Time to Extubation | Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation >=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: >=100 mmHg). | Day 1 (Post-Surgery, from end of study drug inhalation to extubation) |
| Time to Stating Birth Date |
After extubation, the investigator called and asked the patient to state the birth date once every minute and recorded the time the patient could state the birth date. Time from the end of study drug inhalation. |
| Day 1 (Post-Surgery, after extubation) |
| Time to Reaching an Aldrete Score >=8 (Min) | Score includes a ranking of 0-2 (higher shows improvement) in activity, respiration, circulation, consciousness, and O2 saturation (SpO2). After extubation, the investigator observed the patient's condition every 5 minutes until the Aldrete score reached >=8 and recorded the Aldrete scores at 5-minute intervals. | Day 1 (Post-Surgery, after extubation) |
| Time to Clear Consciousness | "Clear consciousness" means that patients responded to investigator's command for physical movement such as "hold my finger tight." | Day 1 (Post-Surgery, from awakening to before extubation) |
| Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance | BIS is used to monitor depth of anesthesia. The BIS monitor provides a single number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 generally indicates an appropriate level for general anesthesia. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate | Rescue medication can include vasopressors and depressors. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate | Rescue medication can include vasopressors and depressors. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Number of Participants Requiring Rescue Medication Due to Arrhythmia | Rescue medication can include vasopressors and depressors. | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
| Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance | Measurement by infrared absorption spectrometry. The concentrations of BLM-240 and sevoflurane at the start of inhalation were set at 3% and 1%,respectively (by vaporizer dial setting). Concentrations are monitored to determine which levels keep the patient in stable condition without requiring rescue treatment. | Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation] |
| Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance | Measurement by infrared absorption spectrometry. Ranges reflecting when concentrations were stable. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). | Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, and just before extubation] |
| End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia | Successfully maintaining anesthesia is defined as keeping the patient in stable condition (systolic pressure 80 to <150 mmHg and heart rate 50 to <100bpm) without requiring rescue treatment or additional dose of opioid analgesics (<=2 ug/kg/hr).If patient was found to have body movement, recall, or memory during anesthetic maintenance, data for such patient were to be excluded from summary statistic calculation. | Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation] |
| Kyoto |
| Japan |
| Nagoya University | Nagoya | Japan |
| Okayama University | Okayama | Japan |
| Osaka University | Osaka | Japan |
| Sapporo Medical University | Sapporo | Japan |
| Hamamatsu University | Shizuoka | Japan |
| Jikei University | Tokyo | Japan |
| Juntendo University | Tokyo | Japan |
| Keio University | Tokyo | Japan |
| Nippon Medical School | Tokyo | Japan |
| NTT East Japan Kanto Medical | Tokyo | Japan |
| Tokai University | Tokyo | Japan |
| Tokyo University | Tokyo | Japan |
| Tokyo Women's Medical University | Tokyo | Japan |
Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| BG002 | Sevoflurane Group | Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| BLM-240 N2O Group |
Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| OG002 | BLM-240 O2 Group | Inhalation of BLM-240 was initiated at 3% (vaporizer dial setting) with o2 (>=30%). The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
| OG003 | Sevoflurane Group | Inhalation of sevoflurane was initiated at 1% (vaporizer dial setting) with N2O at 50-70%. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). |
|
|
| Primary | Number of Participants With Recall/Memory Issues During Anesthetic Maintenance | The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance. | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Primary | Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance | Rescue medication includes vasopressors and depressors. | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Primary | Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% | "Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to <150 mmHg and heart rate 50 to <100 bpm could be maintained " | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Primary | Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% | Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Primary | Overall Assessment of Efficacy | Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug. | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Primary | Time to Extubation | Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation >=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: >=100 mmHg). | FAS | Posted | Mean | Standard Deviation | minutes | Day 1 (Post-Surgery, from end of study drug inhalation to extubation) |
|
|
|
|
| Secondary | Time to Awakening | Time from the end of study drug inhalation. After the end of inhalation of the study drug, the investigator commanded the patient to open his/her eyes once every minute to check whether he/she awoke and recorded the time of awakening. | FAS | Posted | Mean | Standard Deviation | minutes | Day 1 (Post-Surgery, from the end of study drug inhalation to awakening) |
|
|
|
|
| Secondary | Time to Stating Birth Date | After extubation, the investigator called and asked the patient to state the birth date once every minute and recorded the time the patient could state the birth date. Time from the end of study drug inhalation. | FAS | Posted | Mean | Standard Deviation | minutes | Day 1 (Post-Surgery, after extubation) |
|
|
|
|
| Secondary | Time to Reaching an Aldrete Score >=8 (Min) | Score includes a ranking of 0-2 (higher shows improvement) in activity, respiration, circulation, consciousness, and O2 saturation (SpO2). After extubation, the investigator observed the patient's condition every 5 minutes until the Aldrete score reached >=8 and recorded the Aldrete scores at 5-minute intervals. | FAS | Posted | Mean | Standard Deviation | minutes | Day 1 (Post-Surgery, after extubation) |
|
|
|
| Secondary | Time to Clear Consciousness | "Clear consciousness" means that patients responded to investigator's command for physical movement such as "hold my finger tight." | FAS | Posted | Mean | Standard Deviation | minutes | Day 1 (Post-Surgery, from awakening to before extubation) |
|
|
|
| Secondary | Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance | BIS is used to monitor depth of anesthesia. The BIS monitor provides a single number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 generally indicates an appropriate level for general anesthesia. | FAS | Posted | Mean | Standard Deviation | score on a scale | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Secondary | Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate | Rescue medication can include vasopressors and depressors. | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
|
| Secondary | Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate | Rescue medication can include vasopressors and depressors. | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
| Secondary | Number of Participants Requiring Rescue Medication Due to Arrhythmia | Rescue medication can include vasopressors and depressors. | FAS | Posted | Number | participants | Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) |
|
|
|
|
| Secondary | Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance | Measurement by infrared absorption spectrometry. The concentrations of BLM-240 and sevoflurane at the start of inhalation were set at 3% and 1%,respectively (by vaporizer dial setting). Concentrations are monitored to determine which levels keep the patient in stable condition without requiring rescue treatment. | FAS | Posted | Number | percentage | Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation] |
|
|
|
| Secondary | Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance | Measurement by infrared absorption spectrometry. Ranges reflecting when concentrations were stable. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min). | FAS | Posted | Number | percentage | Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, and just before extubation] |
|
|
|
| Secondary | End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia | Successfully maintaining anesthesia is defined as keeping the patient in stable condition (systolic pressure 80 to <150 mmHg and heart rate 50 to <100bpm) without requiring rescue treatment or additional dose of opioid analgesics (<=2 ug/kg/hr).If patient was found to have body movement, recall, or memory during anesthetic maintenance, data for such patient were to be excluded from summary statistic calculation. | FAS | Posted | Mean | Standard Deviation | percentage | Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation] |
|
|
|
| 0 |
| 166 |
| 163 |
| 166 |
| EG001 | BLM 240 N2O Group | 0 | 111 | 5 | 111 | 108 | 111 |
| EG002 | BLM 240 O2 Group | 0 | 55 | 0 | 55 | 55 | 55 |
| EG003 | Sevoflurane Group | 0 | 50 | 2 | 50 | 49 | 50 |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bundle branch block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Granuloma | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral coldness | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| XIth nerve injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood uric acid decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Body temperature decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haematocrit increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Red blood cell count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory rate decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Volume blood decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Foreign body aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal congestion | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Wound haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
Not provided
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| Yes |
|
| Unevaluable |
|
| Yes |
|
| <70% |
|
| <70% |
|
| Sufficient Ability |
|
| Some Ability |
|
| Insufficient Ability |
|
| Inadequate |
|
| Unevaluable |
|
|
| After Awakening |
|
| Before Extubation |
|
| 5 minutes after extubation |
|
| Title | Measurements |
|---|---|
|