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

NCT ID: NCT04906889

Last Updated: 2023-01-12

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-06-01

Brief Summary

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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

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

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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dexmedetomidine-lidocaine

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

Lidocaine Hydrochloride

Intervention Type DRUG

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

remifentanil

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 for 10 minutes followed by the infusion of 0.1-1 ug/kg/h 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

Lidocaine Hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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precedex remifentanil lidocaine

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 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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Young Eun Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor, Department of Anesthesiology and Pain Medicine

Locations

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Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Seoul St.Mary's Hospital

Seocho, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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dexmedetomidine-lidocaine

Identifier Type: -

Identifier Source: org_study_id

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