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

Phase 4

Completed

• Conditions: Inflammatory Bowel Disease; Endoscopy; Sedation
• Interventions: Drug: Propofol; Drug: Midazolam; Drug: Fentanyl

• Registration Number: NCT01934088
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Study Start: 2014-01
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	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
Fentanyl and Midazolam	Fentanyl	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
Fentanyl and Midazolam	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

Primary Outcome Measures

Name	Time	Method
Satisfaction	Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission	Satisfaction points in a post procedure questionnaire.

Secondary Outcome Measures

Name	Time	Method
Pre-disposing factors for satisfaction with procedure and sedation	At admission to the hospital at time 0	pre-operative questionnaire

Trial Locations

Locations (1)

Endoscopy, Gastrounit, Herlev Hospital; 🇩🇰 Herlev, Region H, Denmark