the Effect of Opioid-free General Anesthesia

February 20, 2022 updated by: Young Eun Moon, The Catholic University of Korea

the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy

This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.

Study Type

Interventional

Enrollment (Actual)

78

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-gu
      • Seoul, Seocho-gu, Korea, Republic of, 07651
        • Seoul St.Mary's Hospital
      • 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patient scheduled for gynecological laparoscopic surgery

Exclusion Criteria:

  1. refusal to participate in this study
  2. emergent surgery
  3. chronic pain requiring for pain killer
  4. psychiatric disease
  5. preoperative bradycardia or hypotension
  6. allergy or history of the adverse effect to study drug
  7. pregnancy or lactation

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: opioid-free anesthesia
The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
Drug: Dexmedetomidine Hydrochloride
dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia
Other Names:
  • precedex
Drug: Lidocaine Hydrochloride
lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia
Other Names:
  • lidocaine
ACTIVE_COMPARATOR: opioid anesthesia
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
the quality of recovery
Time Frame: at 24 hour after the completion of surgery
The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.
at 24 hour after the completion of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokine
Time Frame: during surgery
as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.
during 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: Youngeun Moon, MD, Seoul St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2020

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ACTUAL)

September 20, 2021

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (ACTUAL)

June 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFGA

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

product manufactured in and exported from the U.S.

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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