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

NCT01934088 | Completed Phase 4 DMC

• 1 other identifier: 2013052044 v.1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Endoscopy; Sedation

Keywords

Inflammatory Bowel disease; IBD; Sedation; NAPS; Propofol; Midazolam; Satisfaction; Feasibility

Outcome Measures

Primary Outcomes (1)

• Satisfaction

  Satisfaction points in a post procedure questionnaire.

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

Secondary Outcomes (1)

• Pre-disposing factors for satisfaction with procedure and sedation

  At admission to the hospital at time 0

Other Outcomes (2)

• Correlation between quality of sedation and satisfaction

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

• Feasibilty of method

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

Study Arms (2)

Propofol

EXPERIMENTAL

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

Drug: Propofol

Fentanyl and Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam; Drug: Fentanyl

Interventions

Propofol DRUG

Propofol

Midazolam DRUG

Also known as: Midazolam "Hameln" ATC-code: N05CD08

Fentanyl and Midazolam

Fentanyl DRUG

Also known as: Fentanyl "Hameln" ATC-code: N01AH01

Fentanyl and Midazolam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Endoscopy, Gastrounit, Herlev Hospital

Herlev, Region H, 2730, Denmark

Location

Related Publications (2)

• Jensen JT, Vilmann P, Horsted T, Hornslet P, Bodtger U, Banning A, Hammering A. Nurse-administered propofol sedation for endoscopy: a risk analysis during an implementation phase. Endoscopy. 2011 Aug;43(8):716-22. doi: 10.1055/s-0030-1256515. Epub 2011 Aug 2.

  PMID: 21811940 BACKGROUND

• Steenholdt C, Jensen JT, Brynskov J, Moller AM, Limschou AC, Konge L, Vilmann P. Patient Satisfaction of Propofol Versus Midazolam and Fentanyl Sedation During Colonoscopy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2022 Mar;20(3):559-568.e5. doi: 10.1016/j.cgh.2020.10.037. Epub 2020 Oct 22.

  PMID: 33371995 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Personal Satisfaction

Interventions

Propofol; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jeppe Thue Jensen, MD

  Gastroenheden D, endoscopy, Herlev Hospital

  PRINCIPAL INVESTIGATOR

• Peter Vilmann, Professor

  Gastroenheden D, Endoscopy, Herlev Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: September 4, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

DK (1)