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The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success.
This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of sevoflurane anaesthesia in difficult to intubate (DTI; Mallampati Score III or IV) Egyptian patients who had been prescribed sevoflurane for anaesthesia by their treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difficult to Intubate (DTI) Participants | Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Successful Intubation (Clinical Success) | Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure. | Start of intubation to completion of intubation (up to 15 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration of Induction (in Seconds) | The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all. |
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Inclusion Criteria:
1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV
2. Patients with at least one of the below criteria:
Anatomic
Trauma - neck or face
Burns - airway edema
Infections - edema
Neoplasms; e.g., laryngeal tumors
Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
Diabetes mellitus
Waxy skin - palm test
Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
airway closure in supine position
Morbid obesity (body mass index [BMI] >35)
Airway edema
Laryngospasm
Edentulous patients - indent cheeks.
3. Patients willing to sign informed consent
Exclusion Criteria:
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Hospitals with operation theaters
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| Name | Affiliation | Role |
|---|---|---|
| Amr Alaa | AbbVie Egypt | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 97 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant did not meet the criteria Mallampati Score III or IV and was excluded from the per protocol population, which consisted of 96 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Difficult to Intubate (DTI) Participants | Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Difficult to Intubate (DTI) Participants | Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling. |
| 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 | Percentage of Participants With Successful Intubation (Clinical Success) | Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure. | Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria. | Posted | Number | percentage of participants | Start of intubation to completion of intubation (up to 15 minutes) |
|
All AEs were collected from the time of study drug administration to end of intubation procedure (up to 30 minutes); SAEs were also collected from the time that informed consent was obtained until 30 days after last dose of study drug (30 days).
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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 | Difficult to Intubate (DTI) Participants | Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
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| From start of induction up to 15 minutes |
| Percentage of Participants With Mallampati Score III and IV | Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation. | Screening |
| Mean Duration of Intubation Procedure (in Minutes) | The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]). | Start of intubation to completion of intubation (up to 15 minutes) |
| Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure | The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration. | Start of intubation to completion of intubation (up to 15 minutes) |
| Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane | The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes. | From start of induction to completion of intubation (up to 30 minutes) |
| Mean Number of Intubation Attempts | Start of intubation to completion of intubation (up to 15 minutes) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Mean Duration of Induction (in Seconds) | The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all. | Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria. | Posted | Mean | Standard Error | seconds | From start of induction up to 15 minutes |
|
|
|
| Secondary | Percentage of Participants With Mallampati Score III and IV | Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation. | Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria. | Posted | Number | percentage of participants | Screening |
|
|
|
| Secondary | Mean Duration of Intubation Procedure (in Minutes) | The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]). | Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria. | Posted | Mean | Standard Error | minutes | Start of intubation to completion of intubation (up to 15 minutes) |
|
|
|
| Secondary | Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure | The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration. | ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery. | Posted | Number | percentage of participants | Start of intubation to completion of intubation (up to 15 minutes) |
|
|
|
| Secondary | Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane | The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes. | ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery. | Posted | Number | percentage of participants | From start of induction to completion of intubation (up to 30 minutes) |
|
|
|
| Secondary | Mean Number of Intubation Attempts | Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria. | Posted | Mean | Standard Error | number of attempts | Start of intubation to completion of intubation (up to 15 minutes) |
|
|
|
| 0 |
| 97 |
| 2 |
| 97 |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.