NCT03388151

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

6.6 years

First QC Date

December 23, 2017

Last Update Submit

August 23, 2018

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Number of patients adequately sedated

    The number of patients adequately sedated

    6 months

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

MidazolamDRUG

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

Midazolam
PropofolDRUG

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

Propofol

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver cirrhosis
  • presented to colonoscopy

You may not qualify if:

  • Encephalopathy
  • Hypersensitivity
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

MidazolamPropofol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sherief Abd-Elsalam, MD

    Gastroenterology

    PRINCIPAL INVESTIGATOR

  • Sameh Abdelkhalek Ahmed, MD

    Tanta University Anasthesia Department

    STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 2, 2018

Study Start

April 1, 2016

Primary Completion

November 11, 2022

Study Completion

December 11, 2022

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

EG(1)