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

Copenhagen University Hospital at Herlev

Status and phase: Completed; Phase 4

Conditions: Inflammatory Bowel Disease; Sedation; Endoscopy

Treatments: Drug: Midazolam; Drug: Fentanyl; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01934088

2013052044 v.1

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Propofol

Experimental group

Description:

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

Treatment:

Drug: Propofol

Fentanyl and Midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Midazolam