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Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.

NCT03063866 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-27

No results posted yet for this study

Summary

Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.

In conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.

Conditions

Interventions

DRUG

Propofol

Propofol 1 mg/kg i.v

DRUG

Midazolam

Midazolam 3 mg i.v

DRUG

Fentanyl

fentanyl 0.5 ug/kg

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Sherief Abd-Elsalam

    lead OTHER

Principal Investigators

  • Sameh Abdelkhalek Ahmed, MD · Tanta University Faculty of Medicine

  • Sherief Abd-Elsalam, MD · Tanta university Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2018-03-31
Completion
2018-04-30

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063866 on ClinicalTrials.gov