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Clinical Trials/NCT03171610
NCT03171610CompletedNot Applicable

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

Yonsei University1 site in 1 country82 target enrollmentStarted: June 13, 2017Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
1
Primary Endpoint
Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Sufentanil group

Experimental

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

Intervention: Sufentanil group (Drug)

Fentanyl group

Active Comparator

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

Intervention: Fentanyl group (Drug)

Outcomes

Primary Outcomes

Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)

Time Frame: 24 hrs after recovery room discharge

Incidence of postoperative nausea and vomiting (PONV)

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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