- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906889
the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
January 10, 2023 updated by: Young Eun Moon, The Catholic University of Korea
The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy
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
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seocho, Korea, Republic of, 06591
- Seoul St.Mary's Hospital
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Seocho-gu
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Seoul, Seocho-gu, Korea, Republic of, 06591
- Seoul St.Mary's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dexmedetomidine-lidocaine
The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
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dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
Other Names:
lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia
Other Names:
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Active Comparator: remifentanil
The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy
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remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain in recovery room
Time Frame: 30 minuetes after the completion of surgery
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The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
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30 minuetes after the completion of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
shivering in recovery room
Time Frame: 30 minuetes after the completion of surgery
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The incidence of shivering is assessed by questioning Yes or No.
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30 minuetes after the completion of surgery
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postoperative nausea and vomiting (PONV)
Time Frame: 30 minutes after the completion of surgery
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The incidence of PONV is assessed by questioning Yes or No
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30 minutes after the completion of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Young Eun Moon, MD, PhD, Associate professor, Department of Anesthesiology and Pain Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Anticipated)
May 30, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
May 25, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
May 28, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2023
Last Update Submitted That Met QC Criteria
January 10, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Remifentanil
- Dexmedetomidine
- Lidocaine
Other Study ID Numbers
- dexmedetomidine-lidocaine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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