Trial Outcomes & Findings for Sedation Regimens in GI Endoscopy (NCT NCT04807101)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

300 participants

Primary outcome timeframe

1 day

Results posted on

2024-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Midazolam and Fentanyl Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Overall Study STARTED	152	148
Overall Study COMPLETED	152	148
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation	Total n=300 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 11.1 • n=152 Participants	52.3 years STANDARD_DEVIATION 10.4 • n=148 Participants	52.3 years STANDARD_DEVIATION 10.7 • n=300 Participants
Sex: Female, Male Female	72 Participants n=152 Participants	61 Participants n=148 Participants	133 Participants n=300 Participants
Sex: Female, Male Male	80 Participants n=152 Participants	87 Participants n=148 Participants	167 Participants n=300 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	152 participants n=152 Participants	148 participants n=148 Participants	300 participants n=300 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Pain Felt During the Procedure	0.29 score on a scale Standard Deviation 1.2	0.30 score on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Adequacy of Sedation	-0.28 score on a scale Standard Deviation 0.94	-0.094 score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: 1 day

Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?"

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Patient Reported Nausea	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 day

Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Adverse Events	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Cecal Intubation Rate	152 Participants	148 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Cecal Intubation Time	6.97 minutes Standard Deviation 3.10	7.99 minutes Standard Deviation 3.66

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Colonoscopy Withdrawal Time	16.44 minutes Standard Deviation 4.01	16.29 minutes Standard Deviation 4.34

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Midazolam and Fentanyl n=152 Participants Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 Participants Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
Adenoma Detection Rate	58 Participants	54 Participants

Adverse Events

Midazolam and Fentanyl

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Midazolam Alone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Midazolam and Fentanyl n=152 participants at risk Patients in this arm will receive standard conscious sedation with midazolam and fentanyl	Midazolam Alone n=148 participants at risk Patients in this arm will receive conscious sedation with medazepam alone midazolam alone: elimination of fentanyl from conscious sedation
General disorders procedure interrupted due to pain	0.66% 1/152 • Number of events 1 • 1 day oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted	1.4% 2/148 • Number of events 2 • 1 day oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted

Additional Information

Greg Cohen, MD

Northwestern University

Phone: 312-695-4452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place