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Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy
This study is currently recruiting participants.
Verified July 2017 by Kateryna Bielka, Bogomolets National Medical University
Sponsor:
Bogomolets National Medical University
Information provided by (Responsible Party):
Kateryna Bielka, Bogomolets National Medical University
ClinicalTrials.gov Identifier:
NCT03211871
First received: July 4, 2017
Last updated: July 6, 2017
Last verified: July 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Pain, Postoperative | Drug: Dexmedetomidine Drug: Normal Saline Flush, 0.9% Injectable Solution_#1 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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: No maskingPrimary Purpose: Treatment |
| Official Title: | Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy: Randomized Controlled Study |
Resource links provided by NLM:
Further study details as provided by Kateryna Bielka, Bogomolets National Medical University:
Primary Outcome Measures:
- 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
- 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
- morphine consumption [ Time Frame: 48 hours ]total morphine consumption after surgery in mg
Secondary Outcome Measures:
- Time of extubation [ Time Frame: 24 hours after surgery ]Time from end of surgery to extubation
- Incidence of chronic postoperative pain [ Time Frame: 6 month after surgery ]number of patients with chronic postoperative pain
| Estimated Enrollment: | 60 |
| Actual Study Start Date: | May 1, 2016 |
| Estimated Study Completion Date: | October 1, 2017 |
| Estimated Primary Completion Date: | August 1, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT03211871
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211871
Contacts
| Contact: Kateryna Bielka | 380936693931 | ekateryna.belka@gmail.com |
Locations
| Ukraine | |
| Kyiv Clinical City Hospital #1 | Recruiting |
| Kyiv, Ukraine, 02140 | |
| Contact: Iurii Kuchyn, Prof 380677275825 kuchyn2@gmail.com | |
Sponsors and Collaborators
Bogomolets National Medical University
More Information
| Responsible Party: | Kateryna Bielka, assistant professor at Anesthesiology and intensive care Department, Bogomolets National Medical University |
| ClinicalTrials.gov Identifier: | NCT03211871 History of Changes |
| Other Study ID Numbers: |
87678 |
| Study First Received: | July 4, 2017 |
| Last Updated: | July 6, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | IPD will not be available |
| 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:
|
Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Dexmedetomidine Analgesics 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 |
ClinicalTrials.gov processed this record on July 11, 2017