Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy

NCT03211871 | Unknown Phase 3

• 1 other identifier: 87678
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

pain management, dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• number of patients with severe pain

  number of patients with severe pain estimated as VAS≥7 during 30% or more time in first 48 hours after surgery

  48 hours after surgery

• Time to first rescue analgesia

  time from end of anesthesia to the time postoperatively when patient ask for analgesia or have VAS≥4

  24 hours after surgery

• morphine consumption

  total morphine consumption after surgery in mg

  48 hours

Secondary Outcomes (2)

• Time of extubation

  24 hours after surgery

• Incidence of chronic postoperative pain

  6 month after surgery

Study Arms (2)

Group D

ACTIVE COMPARATOR

Group D received dexmedetomidine infusion 0,5 mcg/kg/h from induction in anesthesia to extubation

Drug: Dexmedetomidine

Croup C

PLACEBO COMPARATOR

group C (control) received normal saline infusion

Drug: Normal Saline Flush, 0.9% Injectable Solution_#1

Interventions

Dexmedetomidine DRUG

Intraoperative intravenous dexmedetomidine infusion 0,5 mcg/kg/h

Group D

Normal Saline Flush, 0.9% Injectable Solution_#1 DRUG

Intraoperative intravenous normal saline infusion

Croup C

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Kyiv Clinical City Hospital #1

Kyiv, 02140, Ukraine

RECRUITING

Related Publications (1)

• Bielka K, Kuchyn I, Babych V, Martycshenko K, Inozemtsev O. Dexmedetomidine infusion as an analgesic adjuvant during laparoscopic small es, Cyrillicholecystectomy: a randomized controlled study. BMC Anesthesiol. 2018 Apr 20;18(1):44. doi: 10.1186/s12871-018-0508-6.

  PMID: 29678158 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Kateryna Bielka

CONTACT

380936693931; ekateryna.belka@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor at Anesthesiology and intensive care Department

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 7, 2017
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

UA (1)