Trials Sponsors Conditions Drugs Pricing

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:

Sponsors & Collaborators

Yonsei University
Otherlead

Study Sites (1)

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

Seoul, 03722, South Korea

Enrollment

82 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Sufentanil group

Fentanyl group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Sufentanil group

Fentanyl group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations