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

Phase 4CompletedNCT01934088

Copenhagen University Hospital at Herlev130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Inflammatory Bowel Disease Endoscopy Sedation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Satisfaction

Satisfaction points in a post procedure questionnaire.

Time frame: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission

Secondary Outcomes

Pre-disposing factors for satisfaction with procedure and sedation

pre-operative questionnaire

Time frame: At admission to the hospital at time 0