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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063866
Recruitment Status : Unknown
Verified April 2017 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : February 24, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Liver Diseases Drug: Propofol Drug: Midazolam Drug: Fentanyl Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Randomised Controlled Study Comparing Use of Popofol Plus Fentanyl Versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients With Advanced Liver Disease.
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: M group
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg
 Drug: Midazolam
Midazolam 3 mg i.v
Other Name: Dormicum

Drug: Fentanyl
fentanyl 0.5 ug/kg
Other Name: Fantanyl
Active Comparator: P Group
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v
 Drug: Propofol
Propofol 1 mg/kg i.v
Other Name: propoven

Drug: Fentanyl
fentanyl 0.5 ug/kg
Other Name: Fantanyl


Outcome Measures
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Primary Outcome Measures :
  1. Level of sedation [ Time Frame: 6 months ]
    Level of sedation using Ramsay sedation agitation score at before induction of sedation


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063866


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201095159522 Sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Egypt
Contact: Sherief Abd-Elsalam, MD    00201095159522    sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
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Principal Investigator: Sameh Abdelkhalek Ahmed, MD Tanta University Faculty of Medicine
Study Director: Sherief Abd-Elsalam, MD Tanta university Faculty of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sherief Abd-Elsalam, Consultant, Tanta University
ClinicalTrials.gov Identifier: NCT03063866    
Other Study ID Numbers: Sameh 1
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Fentanyl
Midazolam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
 Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action