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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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M group

Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam 3 mg i.v

Fentanyl

Intervention Type DRUG

fentanyl 0.5 ug/kg

P Group

Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol 1 mg/kg i.v

Fentanyl

Intervention Type DRUG

fentanyl 0.5 ug/kg

Interventions

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Propofol

Propofol 1 mg/kg i.v

Intervention Type DRUG

Midazolam

Midazolam 3 mg i.v

Intervention Type DRUG

Fentanyl

fentanyl 0.5 ug/kg

Intervention Type DRUG

Other Intervention Names

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propoven Dormicum Fantanyl

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No