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NCT04906889 Clinical Trial

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

Gynecologic Disease Clinical Trial

Official title:
The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04906889
Other study ID # dexmedetomidine-lidocaine
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date June 1, 2022

Study information
Verified date January 2023
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

This study is performed to investigate the effect of dexmedetomidine and lidocaine the postopeative pain, shivering, nausea and vomiting after the gynecological laparoscopy.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 1, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine Hydrochloride
dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
• Remifentanil Hydrochloride
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
• Lidocaine Hydrochloride
lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia

Locations
Country Name City State
Korea, Republic of Seoul St.Mary's Hospital Seocho
Korea, Republic of Seoul St.Mary's Hospital Seoul Seocho-gu

Sponsors (1)
Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative pain in recovery room The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain) 30 minuetes after the completion of surgery
Secondary shivering in recovery room The incidence of shivering is assessed by questioning Yes or No. 30 minuetes after the completion of surgery
Secondary postoperative nausea and vomiting (PONV) The incidence of PONV is assessed by questioning Yes or No 30 minutes after the completion of surgery
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