Skip to main content
Clinical Trials/NCT04333992
NCT04333992
Completed
N/A

A Comparison of Propofol-remifentanil Versus Sevoflurane-remifentanil: the Effect on Acute Postoperative Pain After Total Shoulder Arthroplasty

Yeungnam University College of Medicine1 site in 1 country48 target enrollmentFebruary 1, 2017

Overview

Phase
N/A
Intervention
propofol and remifentanil
Conditions
Postoperative Pain
Sponsor
Yeungnam University College of Medicine
Enrollment
48
Locations
1
Primary Endpoint
postoperative opioid consumption
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study was performed to compare the acute postoperative pain intensity and opioid consumption after total shoulder arthroplasty between propofol-remifentanil and sevoflurane-remifentanil anesthesia.

Detailed Description

After approval of the Institutional Review Board and written informed consent, 48 patients, aged 18-65 years for shoulder arthroplasty were enrolled in this prospective, randomized, double-blinded study. Patients were assigned to one of two groups : group PR, the propofol-remifentanil group; and group SR, the sevoflurane-remifentanil group. In the group PR, anesthetic induction was achieved with an initial target concentration of propofol 4 ㎍/mL and remifentanil 3-4 ng/mL using target controlled infusion (TCI) devices and rocuronium 0.8 mg/kg. After intubation, anesthesia was maintained with fixed target concentration of propofol 2-4 ㎍/mL and remifentanil 2-3 ng/mL to keep acceptable hemodynamic response and bispectral index (BIS) values 40-60. In the group SR, anesthetic induction was achieved with thiopental 5 mg/kg and initial target concentration of remifentanil 3-4 ng/mL using TCI and rocuronium 0.8 mg/kg. Anesthesia was maintained with 1.5-2.5% end-tidal concentration sevoflurane in 50% oxygen with air and remifentanil 2-3 ng/mL was continuously infused adjusting to maintain an acceptable hemodynamics and BIS values 40-60. The administration of propofol or sevoflurane with remifentanil was stopped at the surgery ended. Postoperative pain intensity was assessed using a numerical rating scale (NRS: 0; no pain, 10; worst pain) at the 30 min, 2, 6, 12, 24 h. Also, the patient-controlled analgesia (PCA) was infused immediately after post anesthetic care unit arrival. The PCA device was set to deliver 0.38 ㎍/kg/h of fentanyl as a basal infusion rate and 20 ㎍ on demand with a 15 min lockout time. The total PCA volume, number of patients to need rescue analgesics was recorded.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
January 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eun Kyung Choi

Professor

Yeungnam University College of Medicine

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) I or II and aged 18-65 years for total shoulder arthroplasty

Exclusion Criteria

  • Use of routinely using analgesics, history of neurologic or psychologic disease, body mass index more than 35 kg/m2, and intake of any sedatives or analgesics within 24 h before surgery

Arms & Interventions

propofol-remifentanil group

Anesthetic induction was achieved with an initial target concentration of propofol 4 ㎍/mL and remifentanil 3-4 ng/mL. Anesthesia was maintained with a fixed target concentration of propofol 2-4 ㎍/mL and remifentanil 2-3 ng/mL

Intervention: propofol and remifentanil

sevoflurane-remifentanil group

Anesthetic induction was achieved with thiopental 5 mg/kg and initial target concentration of remifentanil 3-4 ng/mL. Anesthesia was maintained with 1.5-2.5% end-tidal concentration sevoflurane in 50% oxygen with air and remifentanil 2-3 ng/mL

Intervention: sevoflurane and remifentanil

Outcomes

Primary Outcomes

postoperative opioid consumption

Time Frame: 24 hours after surgery

total patient controlled anesthesia (PCA) volume

postoperative pain intensity

Time Frame: 24 hours after surgery

numerical rating scale 0-10 (NRS: 0; no pain, 10; worst pain)

Study Sites (1)

Loading locations...

Similar Trials