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

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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