the Effect of Opioid-free General Anesthesia

NCT04409964 | Completed DMC

• 1 other identifier: OFGA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

• the quality of recovery

  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 Outcomes (1)

• cytokine

  during surgery

Study Arms (2)

opioid-free anesthesia

EXPERIMENTAL

The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.

Drug: Dexmedetomidine Hydrochloride; Drug: Lidocaine Hydrochloride

opioid anesthesia

ACTIVE COMPARATOR

The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy.

Drug: Remifentanil Hydrochloride

Interventions

Dexmedetomidine Hydrochloride DRUG

dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia

Also known as: precedex

opioid-free anesthesia

Lidocaine Hydrochloride DRUG

lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia

Also known as: lidocaine

opioid-free anesthesia

Remifentanil Hydrochloride DRUG

remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia

Also known as: remifentanil

opioid anesthesia

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: the patients undergoing the gynecological laparoscopic surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient scheduled for gynecological laparoscopic surgery

You may not qualify if:

• refusal to participate in this study
• emergent surgery
• chronic pain requiring for pain killer
• psychiatric disease
• preoperative bradycardia or hypotension
• allergy or history of the adverse effect to study drug
• pregnancy or lactation

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (2)

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

Location

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 07651, South Korea

Location

Related Publications (1)

• Song JY, Choi H, Chae M, Ko J, Moon YE. The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial. Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.

  PMID: 33712080 DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Dexmedetomidine; Lidocaine; Remifentanil

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Study Officials

• Youngeun Moon, MD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 20, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)