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

Yonsei University

Status: Completed

Conditions: Patients Undergoing Laparoscopic Nephrectomy

Treatments: Drug: Fentanyl group; Drug: Sufentanil group

Study type: Interventional

Funder types: Other

Identifiers

NCT03171610

4-2017-0201

Details and patient eligibility

About

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

Enrollment: 82 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups

Sufentanil group

Experimental group

Description:

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

Treatment:

Drug: Sufentanil group

Fentanyl group

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl group