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Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients

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: NCT04906772
Recruitment Status : Active, not recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Tamer Nabil Abdelrahman, Ain Shams University

Brief Summary:
We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations used in hepatic patients with child-Pugh classification (class A), and early (class B) undergoing UGIE.

Condition or disease Intervention/treatment Phase
Anesthesia; Reaction Drug: Dexmedetomidine Drug: Propofol Phase 4

Detailed Description:
70 Patients will be randomly allocated into two groups; Group (KD): Ketamine/dexmedetomidine (35 patients), will receive IV ketamine 0.25mg/kg and dexmedetomidine1µg/kg over 10 min as loading followed by dexmedetomidine infusion with a rate of 0.5µg/kg/hr and Group (KP): ketamine/propofol (35 patients) will receive IV ketamine 0.25 mg/kg loading and propofol 1 mg/kg over 10 min followed by propofol infusion with a rate of 0.5 mg/kg/hr as a control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Group KD
participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
Drug: Dexmedetomidine
participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
Other Name: ketamine

Active Comparator: Group KP
participants received loading of ketamine 1 mg/kg and propofol 1 mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25 µg/kg/hr dexmedetomidine throughout the procedure.
Drug: Propofol
participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
Other Name: ketamine




Primary Outcome Measures :
  1. induction time [ Time Frame: after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached ]
    Time to reach target Ramsay Sedation Score ≥ 3

  2. Recovery time [ Time Frame: after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening ]
    time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hepatic patients with child-Pugh classification (class A), and (class B)
  • American Society of Anesthesiologists physical status II, III
  • aged 18 to 60 years
  • scheduled for elective Upper gastro-intestinal endoscopy.

Exclusion Criteria:

  • emergency gastro-intestinal endoscopy.
  • patients with severe hepatic disorder (Child C) ,
  • chronic neuro-psychiatric disorder,
  • history of neuro-psychiatric drug intake,
  • severe cardiovascular diseases,
  • pregnancy,
  • history of drug abuse, and
  • history of allergy to any of the used drugs in the study

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): NCT04906772


Locations
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Egypt
Faculty of medicine, Ain-Shams university
Cairo, Egypt
Sponsors and Collaborators
Tamer Nabil Abdelrahman
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Responsible Party: Tamer Nabil Abdelrahman, lecturer of anaesthesia, intensive care and pain management, Ain Shams University
ClinicalTrials.gov Identifier: NCT04906772    
Other Study ID Numbers: FAMSU R 21
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021

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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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Dexmedetomidine
Ketamine
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
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents