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Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy

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. Identifier: NCT03211871
Recruitment Status : Unknown
Verified July 2017 by Kateryna Bielka, Bogomolets National Medical University.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Information provided by (Responsible Party):
Kateryna Bielka, Bogomolets National Medical University

Brief Summary:
The aim of this study was to evaluate efficacy and safety of dexmedetomidine infusion during laparoscopic cholecystectomy. The randomized, single-center, controlled study was carried out from May 2016 to June 2017 at department of surgery, anesthesiology and intensive care, Postgraduate Institute of Bogomolets National Medical University.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Dexmedetomidine Drug: Normal Saline Flush, 0.9% Injectable Solution_#1 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After the primary patient assessment, eligible participants were assigned in a 1:1 ratio to either the intervention (Group D) or control (Group C) groups using random assignment in blocks of four.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy: Randomized Controlled Study
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group D
Group D received dexmedetomidine infusion 0,5 mcg/kg/h from induction in anesthesia to extubation
Drug: Dexmedetomidine
Intraoperative intravenous dexmedetomidine infusion 0,5 mcg/kg/h

Placebo Comparator: Croup C
group C (control) received normal saline infusion
Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
Intraoperative intravenous normal saline infusion

Primary Outcome Measures :
  1. number of patients with severe pain [ Time Frame: 48 hours after surgery ]
    number of patients with severe pain estimated as VAS≥7 during 30% or more time in first 48 hours after surgery

  2. Time to first rescue analgesia [ Time Frame: 24 hours after surgery ]
    time from end of anesthesia to the time postoperatively when patient ask for analgesia or have VAS≥4

  3. morphine consumption [ Time Frame: 48 hours ]
    total morphine consumption after surgery in mg

Secondary Outcome Measures :
  1. Time of extubation [ Time Frame: 24 hours after surgery ]
    Time from end of surgery to extubation

  2. Incidence of chronic postoperative pain [ Time Frame: 6 month after surgery ]
    number of patients with chronic postoperative pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients elected for laparoscopic cholecystectomy
  • age between 18 and 79 years
  • either sex
  • ASA physical status I to II

Exclusion Criteria:

  • age outside the specified range
  • pregnancy or lactation
  • severe systemic disease (ASA III physical status or more)
  • patients on b-blockers or calcium channel blockers

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 identifier (NCT number): NCT03211871

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Contact: Kateryna Bielka 380936693931

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Kyiv Clinical City Hospital #1 Recruiting
Kyiv, Ukraine, 02140
Contact: Iurii Kuchyn, Prof    380677275825   
Sponsors and Collaborators
Bogomolets National Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kateryna Bielka, assistant professor at Anesthesiology and intensive care Department, Bogomolets National Medical University Identifier: NCT03211871    
Other Study ID Numbers: 87678
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will not be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kateryna Bielka, Bogomolets National Medical University:
pain management, dexmedetomidine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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