Clinical trial NCT04333992: Propofol Versus Sevoflurane on Acute Postoperative Pain
Official title: A Comparison of Propofol-remifentanil Versus Sevoflurane-remifentanil: the Effect on Acute Postoperative Pain After Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: propofol
sevoflurane
anesthesia
shoulder arthroplasty
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: postoperative pain intensity
timeFrame: 24 hours after surgery
measure: postoperative opioid consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eun kyung Choi
state: Korea (the Republic Of)
Study officials:
References: