An interventional study of Transcutaneous CO2 monitor and Midazolam in Conscious Sedation Failure During Procedure, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Diagnostic
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.
Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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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
Device: Transcutaneous CO2 monitor · Drug: Midazolam · Drug: Nalbuphine · Drug: Lidocaine
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
Device: Transcutaneous CO2 monitor · Drug: Propofol · Drug: Nalbuphine · Drug: Lidocaine
Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group.
Also known as: SenTec digital monitoring and Stow-Severinghaus type sensor
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.
Also known as: Dormicum
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.
Also known as: Diprivan
The starting dose was 2 mg with additional doses of 1 mg if it was necessary.
Also known as: Nubain
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.
Also known as: Xylocaine
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.
Time frame: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60
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.
Time frame: 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).
Time frame: at discharge from bronchoscopy suite, average 60 min from FB start
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.
| Milestone | Midazolam | Propofol |
|---|---|---|
| Started | 49 | 53 |
| Completed | 42 | 49 |
| Not completed | 7 | 4 |
| Withdrew: Lost to follow-up | 7 | 4 |
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.
| Unit of Measure "mmHg" | Midazolam | Propofol |
|---|---|---|
| Change in Transcutaneous CO2 Pressure | 43.6 ± 7.5 | 45.6 ± 9.6 |
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.
| score on a scale | Midazolam | Propofol |
|---|---|---|
| Residual Sedation Assessed Using the Aldrete Scale | 10 (9 to 10) | 10 (10 to 10) |
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).
| score on a scale | Midazolam | Propofol |
|---|---|---|
| Patient Comfort Assessed Using a Satisfaction Questionnaire | 8.41 ± 1.25 | 8.97 ± 0.98 |
Collected over During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Midazolam | 0/49 (0%) | 0/49 (0%) | 13/49 (26.5%) |
| Propofol | 0/53 (0%) | 0/53 (0%) | 11/53 (20.8%) |
| Event | Midazolam | Propofol |
|---|---|---|
| BronchospasmRespiratory, thoracic and mediastinal disorders | 8/49 | 7/53 |
| HypotensionBlood and lymphatic system disorders | 4/49 | 3/53 |
| Respiratory depressionRespiratory, thoracic and mediastinal disorders | 1/49 | 1/53 |
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).
| Age, Categorical(Participants) | Midazolam | Propofol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 42 | 49 | 91 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Midazolam | Propofol | Total |
|---|---|---|---|
| Mean | 51.1 ± 16 | 46.6 ± 16.3 | 48.7 ± 16.2 |
| Sex: Female, Male(Participants) | Midazolam | Propofol | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 28 | 33 | 61 |
| Region of Enrollment(participants) | Midazolam | Propofol | Total |
|---|---|---|---|
| Mexico | 42 | 49 | 91 |
Plan to share: No
The record gives a start of Feb 2014, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2024, 10 years 5 months after primary completion.
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Studies of the drug tested here: Propofol
Hospital Universitario Dr. Jose E. Gonzalez