Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Remifentanil RS1

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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.

Remifentanil RS2

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button.

Meperidine

Group Type ACTIVE_COMPARATOR

Meperidine

Intervention Type DRUG

Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.

Interventions

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Remifentanil

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.

Intervention Type DRUG

Remifentanil

Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button.

Intervention Type DRUG