Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-09-30

Brief Summary

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Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.

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Detailed Description

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Conditions

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Inflammatory Bowel Disease Endoscopy Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

Propofol in refract doses. Induction: 10-60 mg supplemented with 10-30 mg following an age correlated algorithm. Maintenance with refract bolus of 10-20 mg every 1-2 minutes after assessed need and condition

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Fentanyl and Midazolam

0.025-0.05 mg of Fentanyl i.v. minimum 5 minutes before procedure as a single shot. Midazolam 1-2 mg i.v. for induction and 0.5-1 mg i.v. for maintenance after assessing needs and condition

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Other Intervention Names

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Midazolam "Hameln" ATC-code: N05CD08 Fentanyl "Hameln" ATC-code: N01AH01

Eligibility Criteria

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Inclusion Criteria

* Inflammatory Bowel Disease (IBD) or suspected IBD
* Planned Endoscopy
* Candidate for propofol sedation
* willingness to be randomized
* Ability to complete questionnaire

Exclusion Criteria

* Allergy to drugs
* American Society of Anesthesiologists Class III
* Body Mass Index \> 35
* Ventricular retention
* Acute condition
* Severe Chronic obstructive pulmonary disease
* Sleep apnea
* Potentially difficult airway or previous difficulty with anesthesia
* Pregnancy
* \<18 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No