the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy

January 10, 2023 updated by: Young Eun Moon, The Catholic University of Korea

The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy

The aim of this study is to investigate the effect of opioid-free anesthesia using dexmedetomidine and lidocaine instead of remifentanil infusion, on the acute postoperative pain after the gynecological laparoscopy

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study is performed to investigate the effect of dexmedetomidine and lidocaine the postopeative pain, shivering, nausea and vomiting after the gynecological laparoscopy.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seocho, Korea, Republic of, 06591
        • Seoul St.Mary's Hospital
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 06591
        • Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients scheduled for elective gynecological laparoscopy

Exclusion Criteria:

  • emergent surgery
  • cancer surgery
  • chronic pain requiring pain killers
  • psychiatric disease
  • preoperative bradycardia (HR < 50 bpm)
  • allergies
  • pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine-lidocaine
The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
Drug: Dexmedetomidine Hydrochloride
dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
Other Names:
  • precedex
Drug: Lidocaine Hydrochloride
lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia
Other Names:
  • lidocaine
Active Comparator: remifentanil
The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy
Drug: Remifentanil Hydrochloride
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
Other Names:
  • remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain in recovery room
Time Frame: 30 minuetes after the completion of surgery
The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
30 minuetes after the completion of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shivering in recovery room
Time Frame: 30 minuetes after the completion of surgery
The incidence of shivering is assessed by questioning Yes or No.
30 minuetes after the completion of surgery
postoperative nausea and vomiting (PONV)
Time Frame: 30 minutes after the completion of surgery
The incidence of PONV is assessed by questioning Yes or No
30 minutes after the completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Young Eun Moon, MD, PhD, Associate professor, Department of Anesthesiology and Pain Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dexmedetomidine-lidocaine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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