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Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

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: NCT03466632
Recruitment Status : Unknown
Verified March 2018 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Condition or disease Intervention/treatment Phase
Colonic Diseases Drug: Propofol Drug: Dexmedetomidine Phase 3

Detailed Description:
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
Study Design
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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: Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: • Propofol Group
propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..
 Drug: Propofol
propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure.
Active Comparator: • Dexmedetomidine Group
dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure
 Drug: Dexmedetomidine
dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with adequate sedation [ Time Frame: 6 months ]
    the number of patients adequately sedated


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 25-45 years,
  • ASA class I or II,
  • who are scheduled for elective outpatient colonoscopy

Exclusion Criteria:

  • refused to give informed consent
  • if they had known hypersensitivity to the used drugs
  • patients with morbidly obese patients
  • patients with increased risk for airway obstruction as obstructive sleep apnea,
  • Liver diseases
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): NCT03466632


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

Locations
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Egypt
Sameh Abdelkhalek Ahmed Recruiting
Zagazig, Egypt, 35455
Contact: Sameh Abdelkhalek Ahmed, MD    00201095159522    sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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Study Director: Sherief Abd-Elsalam, MD Tanta University
Study Director: Sameh Abdelkhalek Ahmed, MD Tanta University Anasthesia Department
More Information
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Responsible Party: Sherief Abd-Elsalam, Principle investigator, Tanta University
ClinicalTrials.gov Identifier: NCT03466632    
Other Study ID Numbers: dexmedetomidine colonoscopy
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
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
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action