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Status unknownNCT03388151Updated Aug 27, 2018

Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

A Phase 3 interventional study of Midazolam and Propofol in Cirrhosis, Liver, sponsored by Sherief Abd-Elsalam. Status unknown at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study summary

propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy

Read the detailed description

Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.

02

Conditions studied

  • Cirrhosis, Liver
03

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Liver cirrhosis
  • presented to colonoscopy

Exclusion criteria

Exclusion Criteria:

  • Encephalopathy
  • Hypersensitivity
  • Coagulopathy
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Midazolam

    Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation

    Drug: Midazolam

  • Active comparator
    Propofol

    Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation

    Drug: Propofol

Interventions

  • DrugMidazolam

    Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation

  • DrugPropofol

    Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation

05

What researchers measure

Primary outcomes

  1. Number of patients adequately sedated

    The number of patients adequately sedated

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Sherief Abd-Elsalam
    Tanta, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT03388151
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (PhDTropical Medicine, Tanta University) — Sponsor-investigator
First posted
Jan 2, 2018
Start date
Apr 1, 2016
Primary completion
Nov 11, 2022 (estimated)
Completion
Dec 11, 2022 (estimated)
Last update
Aug 27, 2018

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201095159522
Sherief Abd-Elsalam, MD
principal investigator · Gastroenterology
Sameh Abdelkhalek Ahmed, MD
study director · Tanta University Anasthesia Department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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