Propofol Versus Sevoflurane on Acute Postoperative Pain

NCT04333992 | Completed DMC

• 1 other identifier: KNUH 2016-12-009-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

propofol; sevoflurane; anesthesia; shoulder arthroplasty

Outcome Measures

Primary Outcomes (2)

• postoperative pain intensity

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

  24 hours after surgery

• postoperative opioid consumption

  total patient controlled anesthesia (PCA) volume

  24 hours after surgery

Study Arms (2)

propofol-remifentanil group

ACTIVE COMPARATOR

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

sevoflurane-remifentanil group

ACTIVE COMPARATOR

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

propofol and remifentanil DRUG

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

propofol-remifentanil group

sevoflurane and remifentanil DRUG

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

sevoflurane-remifentanil group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) I or II and aged 18-65 years for total shoulder arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Eun kyung Choi

Daegu, Korea (the Republic Of), 41944, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Propofol; Remifentanil; Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: February 1, 2017
• Primary Completion: December 12, 2017
• Study Completion: January 1, 2018
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)