Propofol Versus Sevoflurane on Acute Postoperative Pain

Yeungnam University College of Medicine

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: sevoflurane and remifentanil; Drug: propofol and remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT04333992

KNUH 2016-12-009-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

propofol-remifentanil group

Active Comparator group

Description:

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

Treatment:

Drug: propofol and remifentanil

sevoflurane-remifentanil group

Active Comparator group

Description:

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

Treatment:

Drug: sevoflurane and remifentanil