the Effect of Opioid-free General Anesthesia

Not Applicable

Completed

• Conditions: Gynecologic Disease
• Interventions: Drug: Dexmedetomidine Hydrochloride; Drug: Remifentanil Hydrochloride; Drug: Lidocaine Hydrochloride

• Registration Number: NCT04409964
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Study Start: 2020-06-01
• Study First Posted: 2020-06-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-20
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid-free anesthesia	Dexmedetomidine Hydrochloride	The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
opioid anesthesia	Remifentanil Hydrochloride	The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy.
opioid-free anesthesia	Lidocaine Hydrochloride	The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.

Primary Outcome Measures

Name	Time	Method
the quality of recovery	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.

Secondary Outcome Measures

Name	Time	Method
cytokine	during surgery	as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.

Trial Locations

Locations (1)

Seoul St.Mary's Hospital; 🇰🇷 Seoul, Seocho-gu, Korea, Republic of