Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy

NCT02820051 | Completed Results

• 1 other identifier: NM13-009
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Conscious Sedation Failure During Procedure

Keywords

bronchoscopy; conscious sedation; midazolam; patient comfort; propofol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Residual Sedation Assessed Using the Aldrete Scale

  30 min after ending of the bronchoscopy

• Patient Comfort Assessed Using a Satisfaction Questionnaire

  at discharge from bronchoscopy suite, average 60 min from FB start

Study Arms (2)

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

Device: Transcutaneous CO2 monitor; Drug: Midazolam; Drug: Nalbuphine; Drug: Lidocaine

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

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

Interventions

Transcutaneous CO2 monitor DEVICE

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

Midazolam; Propofol

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.

Also known as: Dormicum

Midazolam

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.

Also known as: Diprivan

Propofol

Nalbuphine DRUG

The starting dose was 2 mg with additional doses of 1 mg if it was necessary.

Also known as: Nubain

Midazolam; Propofol

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.

Also known as: Xylocaine

Midazolam; Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

UANL University Hospital

Monterrey, Nuevo León, 64000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 28410767 DERIVED

MeSH Terms

Interventions

Midazolam; Propofol; Nalbuphine; Lidocaine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Julio E. González-Aguirre
• Organization: UANL

jeglza111@gmail.com

82204444

Study Officials

• Roberto Mercado, MD

  UANL

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., FCCP

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 30, 2016
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)