Anesthesia, Colonoscopy, Conscious Sedation, Endoscopy
Conditions
Brief summary
This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.
Interventions
DRUGmidazolam alone
elimination of fentanyl from conscious sedation
Sponsors
Greg S Cohen MD LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* English-speaking patients * Patients ≥18 years old and ≤75 years old * Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl * Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure
Exclusion criteria
* Patients with an allergy or prior adverse event to either fentanyl or midazolam * Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC) * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners * Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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? |
| 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 |
| 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 |
| Adverse Events | 1 day | Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Midazolam and Fentanyl Patients in this arm will receive standard conscious sedation with midazolam and fentanyl | 152 |
| Midazolam Alone Patients in this arm will receive conscious sedation with medazepam alone
midazolam alone: elimination of fentanyl from conscious sedation | 148 |
| Total | 300 |
Baseline characteristics
| Characteristic | Midazolam Alone | Total | Midazolam and Fentanyl |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 10.4 | 52.3 years STANDARD_DEVIATION 10.7 | 52.3 years STANDARD_DEVIATION 11.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 148 participants | 300 participants | 152 participants |
| Sex: Female, Male Female | 61 Participants | 133 Participants | 72 Participants |
| Sex: Female, Male Male | 87 Participants | 167 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 152 | 0 / 148 |
| other Total, other adverse events | 1 / 152 | 2 / 148 |
| serious Total, serious adverse events | 0 / 152 | 0 / 148 |
Outcome results
Primary
Adequacy of Sedation
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Midazolam and Fentanyl | Adequacy of Sedation | -0.28 score on a scale | Standard Deviation 0.94 |
| Midazolam Alone | Adequacy of Sedation | -0.094 score on a scale | Standard Deviation 0.78 |
Primary
Pain Felt During the Procedure
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Midazolam and Fentanyl | Pain Felt During the Procedure | 0.29 score on a scale | Standard Deviation 1.2 |
| Midazolam Alone | Pain Felt During the Procedure | 0.30 score on a scale | Standard Deviation 1.1 |
Secondary
Adenoma Detection Rate
Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam and Fentanyl | Adenoma Detection Rate | 58 Participants |
| Midazolam Alone | Adenoma Detection Rate | 54 Participants |
Secondary
Adverse Events
Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam and Fentanyl | Adverse Events | 1 Participants |
| Midazolam Alone | Adverse Events | 2 Participants |
Secondary
Cecal Intubation Rate
cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam and Fentanyl | Cecal Intubation Rate | 152 Participants |
| Midazolam Alone | Cecal Intubation Rate | 148 Participants |
Secondary
Cecal Intubation Time
time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Midazolam and Fentanyl | Cecal Intubation Time | 6.97 minutes | Standard Deviation 3.1 |
| Midazolam Alone | Cecal Intubation Time | 7.99 minutes | Standard Deviation 3.66 |
Secondary
Colonoscopy Withdrawal Time
Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Midazolam and Fentanyl | Colonoscopy Withdrawal Time | 16.44 minutes | Standard Deviation 4.01 |
| Midazolam Alone | Colonoscopy Withdrawal Time | 16.29 minutes | Standard Deviation 4.34 |
Secondary
Patient Reported Nausea
Patient reported nausea as assessed by a yes or no answer to the question Do you have any nausea now?
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Midazolam and Fentanyl | Patient Reported Nausea | 1 Participants |
| Midazolam Alone | Patient Reported Nausea | 1 Participants |