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

Not Applicable

Withdrawn

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

• Registration Number: NCT04906889
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2021-06-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
postoperative pain in recovery room	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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