Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial

March 13, 2020 updated by: Yonsei University
The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess the degree of recovery after anesthesia and surgery, and has been validated in previous studies. The present study aims to compare the quality of recovery with the QoR-40 questionnaire, in patients undergoing correctional tibial osteotomy under general anesthesia with either TIVA with propofol or inhalational anesthesia with desflurane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Adult patients over the age of 19 scheduled for cosmetic lower limg lengthening for short stature, or correctional tibial osteotomy for osteoarthritis

Exclusion Criteria:

  1. Patient refusal
  2. Patients with altered mental status
  3. Ejection fraction under 55%
  4. Recent MI, CVA, or major cardiovascular surgery
  5. 3rd degree AV block, 2nd degree AV block with P:QRS ration greater than 3:1
  6. Hemodynamically unstable patients requiring vasopressors or oxygen therapy
  7. Febrile patients
  8. Patients with decreased renal function (serum Cr > 0.1 mg/dL)
  9. Patients with known allergies to propofol
  10. Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TIVA group
Drug: propofol and remifentanil
Anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil
ACTIVE_COMPARATOR: Inhalation anesthesia group
Drug: desflurane and remifentanil
Anesthesia is induced and maintained with desflurane and remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QoR-40 score
Time Frame: 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
QoR-40 score
Time Frame: preoperative period to 48 hours after surgery
preoperative period to 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 27, 2016

Primary Completion (ACTUAL)

November 9, 2019

Study Completion (ACTUAL)

November 9, 2019

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (ESTIMATE)

July 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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