Trial · NCT02820051

Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy

NCT02820051, Not applicable, Completed, Hospital Universitario Dr. Jose E. Gonzalez; results first posted 2024-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy. Trials, record NCT02820051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02820051

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy
NCT number: NCT02820051
Status: Completed
Phases: Not applicable
Enrollment: 102 participants, actual
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Conditions: Conscious Sedation Failure During Procedure
Interventions: Transcutaneous CO2 monitor, Midazolam, Propofol, Nalbuphine, Lidocaine
First posted: 2016-06-30
Last updated: 2024-12-02
Results first posted: 2024-12-02
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.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Transcutaneous CO2 Pressure	Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60	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.
Secondary	Residual Sedation Assessed Using the Aldrete Scale	30 min after ending of the bronchoscopy	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.
Secondary	Patient Comfort Assessed Using a Satisfaction Questionnaire	at discharge from bronchoscopy suite, average 60 min from FB start	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).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Transcutaneous CO2 Pressure	Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60	Unit of Measure mmHg	MEAN
SECONDARY	Residual Sedation Assessed Using the Aldrete Scale	30 min after ending of the bronchoscopy	score on a scale	MEDIAN
SECONDARY	Patient Comfort Assessed Using a Satisfaction Questionnaire	at discharge from bronchoscopy suite, average 60 min from FB start	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Transcutaneous CO2 Pressure	Midazolam	43.6	Standard Deviation 7.5	Unit of Measure mmHg
Change in Transcutaneous CO2 Pressure	Propofol	45.6	Standard Deviation 9.6	Unit of Measure mmHg
Residual Sedation Assessed Using the Aldrete Scale	Midazolam	10	Inter-Quartile Range 9 to 10	score on a scale
Residual Sedation Assessed Using the Aldrete Scale	Propofol	10	Inter-Quartile Range 10 to 10	score on a scale
Patient Comfort Assessed Using a Satisfaction Questionnaire	Midazolam	8.41	Standard Deviation 1.25	score on a scale
Patient Comfort Assessed Using a Satisfaction Questionnaire	Propofol	8.97	Standard Deviation 0.98	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Midazolam	49
Overall Study	STARTED	Propofol	53
Overall Study	COMPLETED	Midazolam	42
Overall Study	COMPLETED	Propofol	49
Overall Study	NOT COMPLETED	Midazolam	7
Overall Study	NOT COMPLETED	Propofol	4

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bronchospasm	Respiratory, thoracic and mediastinal disorders	Midazolam	8	49	8
other	Bronchospasm	Respiratory, thoracic and mediastinal disorders	Propofol	7	53	7
other	Respiratory depression	Respiratory, thoracic and mediastinal disorders	Midazolam	1	49	1
other	Respiratory depression	Respiratory, thoracic and mediastinal disorders	Propofol	1	53	1
other	Hypotension	Blood and lymphatic system disorders	Midazolam	4	49	4
other	Hypotension	Blood and lymphatic system disorders	Propofol	3	53	3

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Midazolam	0	49
Total, all-cause mortality	Propofol	0	53
Total, other adverse events	Midazolam	13	49
Total, other adverse events	Propofol	11	53
Total, serious adverse events	Midazolam	0	49
Total, serious adverse events	Propofol	0	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28410767	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Midazolam vs Propofol: deaths from any cause	Trial comparisons
Midazolam vs Propofol: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02820051

GET https://conductscience.org/api/trials/v1/NCT02820051/registered

API reference For AI assistants