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Propofol Versus Sevoflurane on Acute Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol and remifentanil
sevoflurane and remifentanil
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring propofol, sevoflurane, anesthesia, shoulder arthroplasty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eun kyung Choi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol-remifentanil group

sevoflurane-remifentanil group

Arm 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

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

Outcomes

Primary Outcome Measures

postoperative pain intensity
numerical rating scale 0-10 (NRS: 0; no pain, 10; worst pain)
postoperative opioid consumption
total patient controlled anesthesia (PCA) volume

Secondary Outcome Measures

Full Information

First Posted
April 1, 2020
Last Updated
April 1, 2020
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04333992
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
propofol, sevoflurane, anesthesia, shoulder arthroplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propofol-remifentanil group
Arm Type
Active Comparator
Arm 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
Arm Title
sevoflurane-remifentanil group
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
propofol and remifentanil
Intervention Description
intravenous propofol and remifentanil using target-controlled infusion (TCI) devices
Intervention Type
Drug
Intervention Name(s)
sevoflurane and remifentanil
Intervention Description
inhalator sevoflurane and remifentanil using target-controlled infusion (TCI) devices
Primary Outcome Measure Information:
Title
postoperative pain intensity
Description
numerical rating scale 0-10 (NRS: 0; no pain, 10; worst pain)
Time Frame
24 hours after surgery
Title
postoperative opioid consumption
Description
total patient controlled anesthesia (PCA) volume
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eun kyung Choi
City
Daegu
State/Province
Korea (the Republic Of)
ZIP/Postal Code
41944
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Propofol Versus Sevoflurane on Acute Postoperative Pain

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