An interventional study of propofol and remifentanil and sevoflurane and remifentanil in Postoperative Pain, sponsored by Yeungnam University College of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by Yeungnam University College of Medicine · Not applicable, Interventional, and Prevention
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.
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.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 48 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
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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
Drug: propofol and remifentanil
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
Drug: sevoflurane and remifentanil
intravenous propofol and remifentanil using target-controlled infusion (TCI) devices
inhalator sevoflurane and remifentanil using target-controlled infusion (TCI) devices
postoperative pain intensity
numerical rating scale 0-10 (NRS: 0; no pain, 10; worst pain)
Time frame: 24 hours after surgery
postoperative opioid consumption
total patient controlled anesthesia (PCA) volume
Time frame: 24 hours after surgery
Plan to share: Yes
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Yeungnam University College of Medicine