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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 3, 2018

Interventions

  • Drug: Sufentanil group
    • 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.
  • Drug: Fentanyl group
    • 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.

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • postoperative pain score
    • Time Frame: 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)

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor

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