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

Randomised Controlled Study Comparing Use of Popofol Plus Fentanyl Versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients With Advanced Liver Disease.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03063866
Enrollment
100
Registered
2017-02-24
Start date
2017-02-21
Completion date
2018-04-30
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Brief 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.

Detailed description

The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.

Interventions

DRUGFentanyl

fentanyl 0.5 ug/kg

DRUGPropofol

Propofol 1 mg/kg i.v

DRUGMidazolam

Midazolam 3 mg i.v

Sponsors

Tanta University
CollaboratorOTHER
Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged between 40 and 60 years old. * With Child score B or C * Presented for elective gastrointestinal endoscopy

Exclusion criteria

* Emergent condition like hematemesis. * Patients with moderate to severe hepatic encephalopathy. * Patients with hepatopulmonary syndrome. * Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Level of sedation6 monthsLevel of sedation using Ramsay sedation agitation score at before induction of sedation

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, MD
Sheriefabdelsalam@yahoo.com00201095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026