the Effect of Opioid-free General Anesthesia

NCT ID: NCT04409964

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-09-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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opioid-free anesthesia

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

Group Type EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type DRUG

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

Lidocaine Hydrochloride

Intervention Type DRUG

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

opioid anesthesia

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

Group Type ACTIVE_COMPARATOR

Remifentanil Hydrochloride

Intervention Type DRUG

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

Interventions

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Dexmedetomidine Hydrochloride

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

Intervention Type DRUG

Lidocaine Hydrochloride

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

Intervention Type DRUG

Remifentanil Hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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precedex lidocaine remifentanil

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Young Eun Moon

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youngeun Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33712080 (View on PubMed)

Other Identifiers

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OFGA

Identifier Type: -

Identifier Source: org_study_id

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