Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy

Official Title
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Randomized Double-blind Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy

Conditions
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Patients Undergoing Laparoscopic Nephrectomy

Intervention / Treatment
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* Drug: Sufentanil group
* Drug: Fentanyl group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing laparoscopic or robot-assisted laparoscopic nephrectomy (total or partial) patient who want intravenous PCA for postoperative pain control Exclusion Criteria: long-term use of opioid, pain reliever or tranquilizers a history of DM neuritis prolonged prothrombin time or activated partial thromboplastin time impairment of cognitive function obesity (BMI ≥ BMI 30 kg/m2)

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

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil group<br>Arm Description: PCA with sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml | Drug: Sufentanil group<br>* PCA device containing sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.<br>|
| Active Comparator: Fentanyl group<br>PCA with fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml | Drug: Fentanyl group<br>* PCA device containing fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV) | Incidence of postoperative nausea and vomiting (PONV) | 24 hrs after recovery room discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | NRPS (numerical verbal rating score of pain) | at arrival to recovery room, 30 minutes after arrival to recovery room, 1 hour after recovery room discharge, 6 hrs after recovery room discharge, 24 hrs after recovery room discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic nephrectomy, Patient-controlled analgesia (PCA), sufentanil, fentanyl