Trial Outcomes & Findings for Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy (NCT NCT01693185)

Results Overview

Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit Aldrete score * Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0 * O2 saturation: Maintains \> 92% on room air =2, Needs O2 inhalation to maintain O2 saturation \> 90% =1 , O2 saturation \< 90% even with supplemental oxygen =0 * Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0 * Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0 * Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0 To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and -R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

every 5 minutes after completing colonoscopy up to 30 min

Results posted on

2014-06-18

Participant Flow

Predetermined patient identification numbers and enrolment order were placed in sealed envelopes, and all patients were randomly assigned, at recruitment, to the midazolam-meperidine combination (group-MM) or remifentanil alone (group-R). If a patient was excluded during the study, the following patient assumed the status of the excluded patient.

The exclusion criteria were applied. If a patient was excluded after recruitment and enrollment into the study, the following new patient assumed the status of the excluded patient.

Participant milestones

Participant milestones
Measure	Remifentanil remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Overall Study STARTED	27	33
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Remifentanil remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Overall Study diagnostic procedure after colonoscopy	0	6

Baseline Characteristics

Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil	Total n=54 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 12.7 • n=5 Participants	53.0 years STANDARD_DEVIATION 10.7 • n=7 Participants	54.8 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: every 5 minutes after completing colonoscopy up to 30 min

Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit Aldrete score * Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0 * O2 saturation: Maintains \> 92% on room air =2, Needs O2 inhalation to maintain O2 saturation \> 90% =1 , O2 saturation \< 90% even with supplemental oxygen =0 * Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0 * Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0 * Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0 To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and -R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference.

Outcome measures

Outcome measures
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
The Recovery Time	0 minute Interval 0.0 to 10.0	30 minute Interval 15.0 to 30.0

SECONDARY outcome

Timeframe: during and after colonoscopy

patients sound "Ah" at feeling pain during colonosocpy: if a patients sounds "Ah" \> 6 times, the patient was assumed to feel frequent pain.

Outcome measures

Outcome measures
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Participants Assumed to Feel Frequent Pain	4 participants	7 participants

SECONDARY outcome

Timeframe: every 5 min during and after colonoscopy

Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100

Outcome measures

Outcome measures
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Bispectra Lindex Score	92 units on a scale Interval 85.0 to 96.0	84 units on a scale Interval 80.0 to 87.0

SECONDARY outcome

Timeframe: 5 min after the end of colonoscopy

patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100

Outcome measures

Outcome measures
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Patient's Distress Score	37 units on a scale Interval 30.0 to 43.0	30 units on a scale Interval 30.0 to 30.0

SECONDARY outcome

Timeframe: 5 min after the colonoscopy

endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm

Outcome measures

Outcome measures
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Endoscopist Satisfaction	5 units on a scale Interval 5.0 to 10.0	20 units on a scale Interval 10.0 to 20.0

SECONDARY outcome

Timeframe: after colonoscopy

The numbers of patients who recalled instructions and explanations given during colonoscopy

Outcome measures

Outcome measures
Measure	Remifentanil n=27 Participants remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine) Remifentanil: continuous infusion 0.4 mcg/kg/min placebo (for midazolam): normal saline mimic to midazolam injection placebo (for meperidine): normal saline mimic meperidine injection	Midazolam and Meperidine n=27 Participants a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil) Midazolam: bolus injection Meperidine: bolus injection for 30 sec 1.0 mg/kg placebo (for remifentanil): normal saline mimic diluted remifentanil
Indigence of Patient's Recall	27 participants	13 participants

Adverse Events

Remifentanil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam and Meperidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tae-Yop Kim, Professor of Anesthesiology

Konkuk University Medical Center

Phone: 82-2-2030-5445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place