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Trial Outcomes & Findings for Comparison Between Two Different Dosages of Remifentanil During Colonoscopy (NCT NCT01229527)

NCT ID: NCT01229527

Last Updated: 2012-02-01

Results Overview

Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

> 0 minutes

Results posted on

2012-02-01

Participant Flow

Participant milestones

Participant milestones
Measure
Remifentanil RS1
Remifentanil RS2
Meperidine
Overall Study
STARTED
30
30
30
Overall Study
COMPLETED
30
30
30
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Remifentanil RS1
n=30 Participants
Remifentanil RS2
n=30 Participants
Meperidine
n=30 Participants
Total
n=90 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
23 Participants
n=7 Participants
19 Participants
n=5 Participants
62 Participants
n=4 Participants
Age, Categorical
>=65 years
10 Participants
n=5 Participants
7 Participants
n=7 Participants
11 Participants
n=5 Participants
28 Participants
n=4 Participants
Age Continuous
58.93 years
STANDARD_DEVIATION 11.15 • n=5 Participants
55.10 years
STANDARD_DEVIATION 11.82 • n=7 Participants
60.37 years
STANDARD_DEVIATION 10.48 • n=5 Participants
58.13 years
STANDARD_DEVIATION 11.26 • n=4 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
11 Participants
n=7 Participants
16 Participants
n=5 Participants
40 Participants
n=4 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
19 Participants
n=7 Participants
14 Participants
n=5 Participants
50 Participants
n=4 Participants
Region of Enrollment
Italy
30 participants
n=5 Participants
30 participants
n=7 Participants
30 participants
n=5 Participants
90 participants
n=4 Participants

PRIMARY outcome

Timeframe: > 0 minutes

Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.

Outcome measures

Outcome measures
Measure
Remifentanil RS1
n=30 Participants
Remifentanil RS2
n=30 Participants
Meperidine
n=30 Participants
Discharge Time, the Time to Reach a Modified Aldrete Score ≥18
0 minutes
Interval 0.0 to 1.0
0 minutes
Interval 0.0 to 1.0
2 minutes
Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone

The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.

Outcome measures

Outcome measures
Measure
Remifentanil RS1
n=30 Participants
Remifentanil RS2
n=30 Participants
Meperidine
n=30 Participants
Patient's Satisfaction
95.87 units on a scale
Standard Deviation 9.72
93.50 units on a scale
Standard Deviation 12.40
96.27 units on a scale
Standard Deviation 7.62

Adverse Events

Remifentanil RS1

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Remifentanil RS2

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Meperidine

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Remifentanil RS1
n=30 participants at risk
Remifentanil RS2
n=30 participants at risk
Meperidine
n=30 participants at risk
Vascular disorders
Hypotension
16.7%
5/30
13.3%
4/30
20.0%
6/30
Cardiac disorders
Bradycardia
6.7%
2/30
3.3%
1/30
3.3%
1/30
Respiratory, thoracic and mediastinal disorders
Desaturation
0.00%
0/30
10.0%
3/30
3.3%
1/30
Ear and labyrinth disorders
Dizziness
0.00%
0/30
6.7%
2/30
0.00%
0/30
Nervous system disorders
Headache
3.3%
1/30
0.00%
0/30
3.3%
1/30
Psychiatric disorders
Disinhibition
0.00%
0/30
0.00%
0/30
13.3%
4/30
Nervous system disorders
Amnesia
0.00%
0/30
3.3%
1/30
0.00%
0/30
Gastrointestinal disorders
Nausea
0.00%
0/30
0.00%
0/30
13.3%
4/30

Additional Information

Dr. Massimo Agostoni

Department of Anesthesia and Intensive Care

Phone: +39.02.2643.2656

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place