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

Patients Undergoing Laparoscopic Nephrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171610
• Other study ID #: 4-2017-0201
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: March 13, 2018
• Start date: June 13, 2017
• Est. completion date: January 3, 2018

Study information

• Verified date: March 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 3, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Patients Undergoing Laparoscopic Nephrectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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