Propofol Versus Sevoflurane on Acute Postoperative Pain

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

propofol and remifentanil

Intervention Type DRUG

intravenous propofol and remifentanil using target-controlled infusion (TCI) devices

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

Group Type ACTIVE_COMPARATOR

sevoflurane and remifentanil

Intervention Type DRUG

inhalator sevoflurane and remifentanil using target-controlled infusion (TCI) devices

Interventions

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propofol and remifentanil

intravenous propofol and remifentanil using target-controlled infusion (TCI) devices

Intervention Type DRUG

sevoflurane and remifentanil

inhalator sevoflurane and remifentanil using target-controlled infusion (TCI) devices

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No