NCT03171610

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

June 13, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

May 22, 2017

Last Update Submit

March 13, 2018

Conditions

Patients Undergoing Laparoscopic Nephrectomy

Keywords

laparoscopic nephrectomyPatient-controlled analgesia (PCA)sufentanilfentanyl

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

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

Drug: Sufentanil group

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

Drug: Fentanyl group

Interventions

Sufentanil groupDRUG

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.

Sufentanil group
Fentanyl groupDRUG

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.

Fentanyl group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 31, 2017

Study Start

June 13, 2017

Primary Completion

January 3, 2018

Study Completion

January 3, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)