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

NCT ID: NCT03171610

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-13

Study Completion Date

2018-01-03

Brief Summary

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

Detailed Description

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Conditions

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Patients Undergoing Laparoscopic Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sufentanil group

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

Group Type EXPERIMENTAL

Sufentanil group

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Fentanyl group

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2017-0201

Identifier Type: -

Identifier Source: org_study_id

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