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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03171610

Enrollment

Registered

2017-05-31

Start date

2017-06-13

Completion date

2018-01-03

Last updated

2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Laparoscopic Nephrectomy

Keywords

laparoscopic nephrectomy, Patient-controlled analgesia (PCA), sufentanil, fentanyl

Brief summary

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

Interventions

DRUGSufentanil 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.

DRUGFentanyl 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026