Trial · NCT04807101
Sedation Regimens in GI Endoscopy
NCT04807101, Early phase 1, Completed, Greg S Cohen MD LLC; results first posted 2024-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sedation Regimens in GI Endoscopy. Trials, record NCT04807101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04807101
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sedation Regimens in GI Endoscopy
- NCT number
- NCT04807101
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 300 participants, actual
- Lead sponsor
- Greg S Cohen MD LLC
- Conditions
- Anesthesia, Endoscopy, Colonoscopy, Conscious Sedation
- Interventions
- midazolam alone
- First posted
- 2021-03-19
- Last updated
- 2024-04-15
- Results first posted
- 2024-04-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Felt During the Procedure | 1 day | Level of discomfort during the procedure as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "How much discomfort did you experience during the procedure?" A visual analog scale will be used ranging from 0 to 10 with higher numbers indicating more pain. |
| Primary | Adequacy of Sedation | 1 day | Adequacy of sedation as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "If having this procedure again in the future, how much sedation would you prefer to have?" A visual analog scale will be used ranging from -5 to 5, with lower numbers indicating a preference for less sedation in the future and higher numbers indicating a preference for more sedation in the future. |
| Secondary | Patient Reported Nausea | 1 day | Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?" |
| Secondary | Adverse Events | 1 day | Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted |
| Secondary | Cecal Intubation Rate | through study completion, an average of 1 year | cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review |
| Secondary | Cecal Intubation Time | through study completion, an average of 1 year | time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review |
| Secondary | Colonoscopy Withdrawal Time | through study completion, an average of 1 year | Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review |
| Secondary | Adenoma Detection Rate | through study completion, an average of 1 year | Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Felt During the Procedure | 1 day | score on a scale | MEAN | |
| PRIMARY | Adequacy of Sedation | 1 day | score on a scale | MEAN | |
| SECONDARY | Patient Reported Nausea | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Events | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cecal Intubation Rate | through study completion, an average of 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cecal Intubation Time | through study completion, an average of 1 year | minutes | MEAN | |
| SECONDARY | Colonoscopy Withdrawal Time | through study completion, an average of 1 year | minutes | MEAN | |
| SECONDARY | Adenoma Detection Rate | through study completion, an average of 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Felt During the Procedure | Midazolam and Fentanyl | 0.29 | Standard Deviation 1.2 | score on a scale | |
| Pain Felt During the Procedure | Midazolam Alone | 0.30 | Standard Deviation 1.1 | score on a scale | |
| Adequacy of Sedation | Midazolam and Fentanyl | -0.28 | Standard Deviation 0.94 | score on a scale | |
| Adequacy of Sedation | Midazolam Alone | -0.094 | Standard Deviation 0.78 | score on a scale | |
| Patient Reported Nausea | Midazolam and Fentanyl | 1 | Participants | ||
| Patient Reported Nausea | Midazolam Alone | 1 | Participants | ||
| Adverse Events | Midazolam and Fentanyl | 1 | Participants | ||
| Adverse Events | Midazolam Alone | 2 | Participants | ||
| Cecal Intubation Rate | Midazolam and Fentanyl | 152 | Participants | ||
| Cecal Intubation Rate | Midazolam Alone | 148 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Midazolam and Fentanyl | 152 | |
| Overall Study | STARTED | Midazolam Alone | 148 | |
| Overall Study | COMPLETED | Midazolam and Fentanyl | 152 | |
| Overall Study | COMPLETED | Midazolam Alone | 148 | |
| Overall Study | NOT COMPLETED | Midazolam and Fentanyl | 0 | |
| Overall Study | NOT COMPLETED | Midazolam Alone | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | procedure interrupted due to pain | General disorders | Midazolam and Fentanyl | 1 | 152 | 1 |
| other | procedure interrupted due to pain | General disorders | Midazolam Alone | 2 | 148 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Midazolam and Fentanyl | 0 | 152 |
| Total, all-cause mortality | Midazolam Alone | 0 | 148 |
| Total, other adverse events | Midazolam and Fentanyl | 1 | 152 |
| Total, other adverse events | Midazolam Alone | 2 | 148 |
| Total, serious adverse events | Midazolam and Fentanyl | 0 | 152 |
| Total, serious adverse events | Midazolam Alone | 0 | 148 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Midazolam and Fentanyl vs Midazolam Alone: Patient Reported Nausea | Trial comparisons |
| Midazolam and Fentanyl vs Midazolam Alone: Adverse Events | Trial comparisons |
| Midazolam and Fentanyl vs Midazolam Alone: Cecal Intubation Rate | Trial comparisons |
| Midazolam and Fentanyl vs Midazolam Alone: Adenoma Detection Rate | Trial comparisons |
| Midazolam and Fentanyl vs Midazolam Alone: deaths from any cause | Trial comparisons |
| Midazolam and Fentanyl vs Midazolam Alone: 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.
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/NCT04807101
GET https://conductscience.org/api/trials/v1/NCT04807101/registered