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

Study Overview
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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.

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

Conditions
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Gynecologic Disease

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride
* Drug: Remifentanil Hydrochloride
* Drug: Lidocaine Hydrochloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine-lidocaine<br>The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy. | Drug: Dexmedetomidine Hydrochloride<br>* dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia<br>* Other names: precedex;Drug: Lidocaine Hydrochloride<br>* lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia<br>* Other names: lidocaine;|
| Active Comparator: remifentanil<br>The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy | Drug: Remifentanil Hydrochloride<br>* remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia<br>* Other names: remifentanil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shivering in recovery room | The incidence of shivering is assessed by questioning Yes or No. | 30 minuetes after the completion of surgery | 
| postoperative nausea and vomiting (PONV) | The incidence of PONV is assessed by questioning Yes or No | 30 minutes after the completion of surgery |