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NCT02826902 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02826902
Other study ID # 4-2016-0164
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2016
Est. completion date November 9, 2019

Study information
Verified date March 2020
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date November 9, 2019
Est. primary completion date November 9, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• propofol and remifentanil
Anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil
• desflurane and remifentanil
Anesthesia is induced and maintained with desflurane and remifentanil

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary QoR-40 score 24 hours after surgery
Secondary QoR-40 score preoperative period to 48 hours after surgery
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