A Comparison of Propofol-remifentanil Versus Sevoflurane-remifentanil: the Effect on Acute Postoperative Pain After Total Shoulder Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- postoperative opioid consumption
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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 (Drug)
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Eun Kyung Choi
Professor
Yeungnam University College of Medicine