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Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. There is little evidence about transcutaneous CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough inhibition.
The investigators performed a randomized controlled trial to determine whether non-anesthesiology-administered balanced-sedation with propofol was related to high values of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The investigators included data from outpatients 18 years or older with an indication for FB in a university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient satisfaction and adverse effects.
The investigators prospectively included ambulatory patients aged > 18 years with an indication for flexible bronchoscopy. Bronchoscopic procedures were performed by residents of Respiratory and Critical Care Medicine subspecialty under the supervision of an attendant professor in a university-tertiary-referral center in northern Mexico. Patients with tracheostomy, known allergy to drugs used during procedural sedation, inability to answer the satisfaction questionnaires, psychiatric illness, pregnancy, or with ASA class IV or V, were excluded.
Patients were randomly assigned to receive sedation with midazolam or propofol. In the group of midazolam the initial dose was 0.05 mg/kg and in propofol group, the starting dose was 0.1 mg /kg. Additional doses of the corresponding drug (2 mg of midazolam or 10 mg of propofol) were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Prior to insertion of the bronchoscope, lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nasal insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
In both groups, transcutaneous CO2 measurement was carried out with the system SenTec digital monitoring (Artemis Medical, Kent, London) by applying a Stow-Severinghaus (V-Sign sensor) type sensor in the ear lobe. All patients received supplementary oxygen and were monitored with intermittent non-invasive blood pressure measurements every 3 min and with continuous EKG and SO2 surveillance.
The assessment of the state of residual sedation was performed with the Aldrete scale at five, 10 and 15 minutes after complete FB. At the time of discharge from the bronchoscopy suite, a satisfaction questionnaire was applied to patients.
Sedation and analgesia were prescribed by the resident responsible for conducting FB without the support of specialists in anesthesiology. One collaborator blinded to the study group to which each patient belonged recorded all data derived from the procedure. The Bronchoscopist was blinded to PtcCO2 values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Active Comparator | In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor |
|
| Propofol | Experimental | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous CO2 monitor | Device | Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Transcutaneous CO2 Pressure | Our primary outcome was to assess the difference in PtCO2 values during and after FB between the groups. We hypothesized that PtcO2 values are not higher in patients who received NAAP balanced sedation. | Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Sedation Assessed Using the Aldrete Scale | The assessment of the state of residual sedation was performed with the Aldrete scale at minute 30 after complete bronchoscopy. The Aldrete's scoring system is a commonly used scale for determining when people can be safely discharged from the post-anesthesia care unit. The Minumum value is 0 points and the maximum value is 10 pots. Scores of 9 or greater allow patients to leave Post Anaesthetic Care Unit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Mercado, MD | UANL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UANL University Hospital | Monterrey | Nuevo León | 64000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28410767 | Derived | Mercado-Longoria R, Armeaga-Azonos C, Tapia-Orozco J, Gonzalez-Aguirre JE. Non-anesthesiologist-administered Propofol is not Related to an Increase in Transcutaneous CO2 Pressure During Flexible Bronchoscopy Compared to Guideline-based Sedation: A Randomized Controlled Trial. Arch Bronconeumol. 2017 Sep;53(9):489-494. doi: 10.1016/j.arbres.2016.12.018. Epub 2017 Apr 12. English, Spanish. |
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Between February and July 2014, we prospectively included ambulatory patients > 18 years of age with an indication for FB. Bronchoscopic procedures were performed by residents of Respiratory and Critical Care Medicine under the supervision of an attendant professor in a tertiary-referral university hospital in northern Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam | In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg |
| FG001 | Propofol | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We eliminated eleven patients due lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group); finally, we only analyze data from 91 patients (42 in Midazolam and 49 in Propofol groups, respectively).
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam | In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale Nalbuphine: The starting dose was 2 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group) |
| 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 | Change in Transcutaneous CO2 Pressure | Our primary outcome was to assess the difference in PtCO2 values during and after FB between the groups. We hypothesized that PtcO2 values are not higher in patients who received NAAP balanced sedation. | Posted | Mean | Standard Deviation | Unit of Measure "mmHg" | Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60 |
|
During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)
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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 | Midazolam | In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
This study has several limitations: 1) it was not blinded, 2) All patients were ambulatory and with low or intermediate anesthetic risk. 3) In our bronchoscopy service, nalbuphine is the only opioid available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio E. González-Aguirre | UANL | 82204444 | 229 | jeglza111@gmail.com |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D015742 | Propofol |
| D009266 | Nalbuphine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Midazolam | Drug | The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. |
|
|
| Propofol | Drug | The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. |
|
|
| Nalbuphine | Drug | The starting dose was 2 mg with additional doses of 1 mg if it was necessary. |
|
|
| Lidocaine | Drug | Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. |
|
|
| 30 min after ending of the bronchoscopy |
| Patient Comfort Assessed Using a Satisfaction Questionnaire | At the time of discharge from the bronchoscopy suite, satisfaction was assessed using a visual analog scale of 1 (not satisfied) to 10 (very satisfied). | at discharge from bronchoscopy suite, average 60 min from FB start |
| BG001 | Propofol | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group) | Count of Participants | Participants |
|
| Region of Enrollment | Eleven patients were lost to follow-up due to sensor dysfunction (seven in the midazolam group and four in the propofol group) | Number | participants |
|
| OG001 | Propofol | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg |
|
|
|
| Secondary | Residual Sedation Assessed Using the Aldrete Scale | The assessment of the state of residual sedation was performed with the Aldrete scale at minute 30 after complete bronchoscopy. The Aldrete's scoring system is a commonly used scale for determining when people can be safely discharged from the post-anesthesia care unit. The Minumum value is 0 points and the maximum value is 10 pots. Scores of 9 or greater allow patients to leave Post Anaesthetic Care Unit. | Posted | Median | Inter-Quartile Range | score on a scale | 30 min after ending of the bronchoscopy |
|
|
|
|
| Secondary | Patient Comfort Assessed Using a Satisfaction Questionnaire | At the time of discharge from the bronchoscopy suite, satisfaction was assessed using a visual analog scale of 1 (not satisfied) to 10 (very satisfied). | Posted | Mean | Standard Deviation | score on a scale | at discharge from bronchoscopy suite, average 60 min from FB start |
|
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 13 |
| 49 |
| EG001 | Propofol | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. Nalbuphine: The starting dose was 2 mg | 0 | 53 | 0 | 53 | 11 | 53 |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |