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Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

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ClinicalTrials.gov Identifier: NCT03388151
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Drug: Midazolam Drug: Propofol Phase 3

Detailed Description:
Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Use of Propofol Versus Use of Midazolam as Sedative Agent in Patients With Liver Cirrhosis Presented for Lower Gastrointestinal Endoscopy, Randomised Controlled Trial
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : December 11, 2022


Arm Intervention/treatment
Active Comparator: Midazolam
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
Drug: Midazolam
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation

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




Primary Outcome Measures :
  1. Number of patients adequately sedated [ Time Frame: 6 months ]
    The number of patients adequately sedated



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis
  • presented to colonoscopy

Exclusion Criteria:

  • Encephalopathy
  • Hypersensitivity
  • Coagulopathy

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): NCT03388151


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

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Sherief Abd-Elsalam, MD Gastroenterology
Study Director: Sameh Abdelkhalek Ahmed, MD Tanta University Anasthesia Department

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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03388151     History of Changes
Other Study ID Numbers: Propofol colonoscopy
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
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