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

Not Applicable

Completed

• Conditions: Patients Undergoing Laparoscopic Nephrectomy
• Interventions: Drug: Sufentanil group; Drug: Fentanyl group

• Registration Number: NCT03171610
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-05-31
• Study Start: 2017-06-13
• Primary Completion: 2018-01-03
• Study Completion: 2018-01-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. patients undergoing laparoscopic or robot-assisted laparoscopic nephrectomy (total or partial)
2. patient who want intravenous PCA for postoperative pain control

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Exclusion Criteria

1. long-term use of opioid, pain reliever or tranquilizers
2. a history of DM neuritis
3. prolonged prothrombin time or activated partial thromboplastin time
4. impairment of cognitive function
5. obesity (BMI ≥ BMI 30 kg/m2)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil group	Sufentanil group	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
Fentanyl group	Fentanyl group	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

Primary Outcome Measures

Name	Time	Method
Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)	24 hrs after recovery room discharge	Incidence of postoperative nausea and vomiting (PONV)

Secondary Outcome Measures

Name	Time	Method
postoperative pain score	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	NRPS (numerical verbal rating score of pain)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of