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

Primary Purpose

Short Stature, Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

propofol and remifentanil

desflurane and remifentanil

About this trial

This is an interventional other trial for Short Stature focused on measuring Total intravenous anesthesia, desflurane, QoR-40, correctional tibial osteotomy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

TIVA group

Inhalation anesthesia group

Arm Description

Outcomes

Primary Outcome Measures

QoR-40 score

Secondary Outcome Measures

QoR-40 score

Full Information

NCT ID

NCT02826902

First Posted

July 6, 2016

Last Updated

March 13, 2020

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02826902

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

September 27, 2016 (Actual)

Primary Completion Date

November 9, 2019 (Actual)

Study Completion Date

November 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Stature, Osteoarthritis

Keywords

Total intravenous anesthesia, desflurane, QoR-40, correctional tibial osteotomy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TIVA group

Arm Type

Active Comparator

Arm Title

Inhalation anesthesia group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

propofol and remifentanil

Intervention Description

Anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil

Intervention Type

Drug

Intervention Name(s)

desflurane and remifentanil

Intervention Description

Anesthesia is induced and maintained with desflurane and remifentanil

Primary Outcome Measure Information:

Title

QoR-40 score

Time Frame

24 hours after surgery

Secondary Outcome Measure Information:

Title

QoR-40 score

Time Frame

preoperative period to 48 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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

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