CClinicalTrials.gg
CompletedNCT04333992Updated Apr 3, 2020

Propofol Versus Sevoflurane on Acute Postoperative Pain

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

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Feb 2017, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Pain

Browse trials for

Keywords

  • propofol
  • sevoflurane
  • anesthesia
  • shoulder arthroplasty
03

In context

Pain, Postoperative

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.

Browse Pain, Postoperative studies →

Lead sponsor

Yeungnam University College of Medicine is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    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

    Drug: propofol and remifentanil

  • Active comparator
    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

    Drug: sevoflurane and remifentanil

Interventions

  • Drugpropofol and remifentanil

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

  • Drugsevoflurane and remifentanil

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

06

What researchers measure

Primary outcomes

  1. postoperative pain intensity

    numerical rating scale 0-10 (NRS: 0; no pain, 10; worst pain)

    Time frame: 24 hours after surgery

  2. postoperative opioid consumption

    total patient controlled anesthesia (PCA) volume

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Eun kyung Choi
    Daegu, Korea (the Republic Of) 41944, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04333992
Lead sponsor
Yeungnam University College of Medicine
Responsible party
Eun Kyung Choi (Professor, Yeungnam University College of Medicine) — Principal investigator
First posted
Apr 3, 2020
Start date
Feb 1, 2017
Primary completion
Dec 12, 2017
Completion
Jan 1, 2018
Last update
Apr 3, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion