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Completed

NCT Number: NCT01934088

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

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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Key information

Conditions

Inflammatory Bowel Disease Behavior Digestive System Diseases Endoscopy Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Personal Satisfaction Sedation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Endoscopy, Gastrounit, Herlev Hospital

Herlev, Region H, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

midazolam

Drug

Other names: Midazolam "Hameln" ATC-code: N05CD08

Fentanyl

Drug

Other names: Fentanyl "Hameln" ATC-code: N01AH01

Primary outcomes

  1. Satisfaction

    Time frame: 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 outcomes

  1. Pre-disposing factors for satisfaction with procedure and sedation

    Time frame: At admission to the hospital at time 0

    pre-operative questionnaire

Other outcomes

  1. Correlation between quality of sedation and satisfaction

    Time frame: At the end of procedure, an expected average of 1 hour after admission

    Sedation efficacy is measured through use of a previously developed competency assessment tool. The quality of sedation score. The score is correlated with patient satisfaction

  2. Feasibilty of method

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 hours

    Timespand from entering the OR until discharge. Safety parameters during sedation. Number of adverse events, number of airway interventions, number of rescue treatments

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Official study title

Nurse Administered Propofol Sedation vs. Standard Therapy for Colonoscopy in Patients With IBD. A Randomised Controlled Study on Satisfaction and Adherence to Treatment Program.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2013
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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