Colonoscopy
Conditions
Keywords
Colonoscopy, Remifentanil, Sedation
Brief summary
The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects. 90 patients undergoing colonoscopy will be enrolled.
Interventions
DRUGRemifentanil
Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button.
DRUGMeperidine
Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.
Sponsors
Ospedale San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Patients * Diagnostic and Operative Colonoscopy * ASA Physical Status I-II
Exclusion criteria
* Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | > 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Satisfaction | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remifentanil RS1 | 30 |
| Remifentanil RS2 | 30 |
| Meperidine | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Remifentanil RS2 | Meperidine | Remifentanil RS1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 11 Participants | 10 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 19 Participants | 20 Participants | 62 Participants |
| Age Continuous | 55.10 years STANDARD_DEVIATION 11.82 | 60.37 years STANDARD_DEVIATION 10.48 | 58.93 years STANDARD_DEVIATION 11.15 | 58.13 years STANDARD_DEVIATION 11.26 |
| Region of Enrollment Italy | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 11 Participants | 16 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 19 Participants | 14 Participants | 17 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 30 | 9 / 30 | 16 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Discharge Time, the Time to Reach a Modified Aldrete Score ≥18
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.
Time frame: > 0 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remifentanil RS1 | Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | 0 minutes |
| Remifentanil RS2 | Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | 0 minutes |
| Meperidine | Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | 2 minutes |
Secondary
Patient's Satisfaction
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.
Time frame: After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil RS1 | Patient's Satisfaction | 95.87 units on a scale | Standard Deviation 9.72 |
| Remifentanil RS2 | Patient's Satisfaction | 93.50 units on a scale | Standard Deviation 12.4 |
| Meperidine | Patient's Satisfaction | 96.27 units on a scale | Standard Deviation 7.62 |