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Completed

NCT Number: NCT03171610

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

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

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Key information

Conditions

Patients Undergoing Laparoscopic Nephrectomy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sufentanil group

Drug

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.

Fentanyl group

Drug

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.

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 31, 2017
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.