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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04906889
Enrollment
0
Registered
2021-05-28
Start date
2021-06-01
Completion date
2022-06-01
Last updated
2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

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.

Interventions

DRUGDexmedetomidine Hydrochloride

dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia

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

DRUGLidocaine Hydrochloride

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

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain in recovery room30 minuetes after the completion of surgeryThe pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)

Secondary

MeasureTime frameDescription
shivering in recovery room30 minuetes after the completion of surgeryThe incidence of shivering is assessed by questioning Yes or No.
postoperative nausea and vomiting (PONV)30 minutes after the completion of surgeryThe incidence of PONV is assessed by questioning Yes or No

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026