Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy

• ClinicalTrials.gov Identifier: NCT02820051
• Recruitment Status: Completed
• First Posted: June 30, 2016
• Last Update Posted: June 30, 2016
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Information provided by (Responsible Party): Julio Edgardo González Aguirre, Hospital Universitario Dr. Jose E. Gonzalez

Tracking Information

• First Submitted Date: June 22, 2016
• First Posted Date: June 30, 2016
• Last Update Posted Date: June 30, 2016
• Study Start Date: February 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 28, 2016): Change in transcutaneous CO2 pressure [ Time Frame: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 28, 2016)

• Residual sedation assessed using the Aldrete scale [ Time Frame: 15 min after ending of the bronchoscopy ]
  The assessment of the state of residual sedation was performed with the Aldrete scale at minute 15 after complete bronchoscopy.
• Patient comfort assessed using a satisfaction questionnaire [ Time Frame: at discharge from bronchoscopy suite, average 60 min from FB start ]
  At the time of discharge from the bronchoscopy suite, a satisfaction questionnaire was applied to patients.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy
• Official Title: Non-anesthesiologist-administered Propofol is Not Related to a Higher Increase in Transcutaneous CO2 Pressure During the Flexible Bronchoscopy Compared to Guideline-based Sedation: A Randomized Controlled Trial

Brief Summary

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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Diagnostic
• Condition: Conscious Sedation Failure During Procedure

Intervention

• Device: Transcutaneous CO2 monitor
  Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group.
  Other Name: SenTec digital monitoring and Stow-Severinghaus type sensor
• Drug: 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.
  Other Name: Dormicum
• Drug: 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.
  Other Name: Diprivan
• Drug: Nalbuphine
  The starting dose was 2 mg with additional doses of 1 mg if it was necessary.
  Other Name: Nubain
• Drug: Lidocaine
  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.
  Other Name: Xylocaine

Study Arms

• Active Comparator: 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

  Interventions:

  • Device: Transcutaneous CO2 monitor
  • Drug: Midazolam
  • Drug: Nalbuphine
  • Drug: Lidocaine
• Experimental: 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

  Interventions:

  • Device: Transcutaneous CO2 monitor
  • Drug: Propofol
  • Drug: Nalbuphine
  • Drug: Lidocaine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 28, 2016): 91
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Ambulatory patients aged > 18 years with an indication for flexible bronchoscopy.

Exclusion Criteria:

• tracheostomy
• known allergy to drugs used during procedural sedation
• inability to answer the satisfaction questionnaires
• psychiatric illness, pregnancy
• ASA class IV or V

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT02820051
• Other Study ID Numbers: NM13-009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Julio Edgardo González Aguirre, Hospital Universitario Dr. Jose E. Gonzalez
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Roberto Mercado, MD; UANL

• PRS Account: Hospital Universitario Dr. Jose E. Gonzalez
• Verification Date: June 2016