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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02826902
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.4
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Short Stature; Osteoarthritis	Drug: propofol and remifentanil; Drug: desflurane and remifentanil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
• Actual Study Start Date: Sep 27, 2016
• Actual Primary Completion Date: Nov 9, 2019
• Actual Study Completion Date: Nov 9, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. QoR-40 score [24 hours after surgery]

Secondary Outcome Measures

1. QoR-40 score [preoperative period to 48 hours after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02826902
• Other Study ID Numbers: 4-2016-0164
• First Posted: Jul 11, 2016
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yonsei University: Total intravenous anesthesia; desflurane; QoR-40; correctional tibial osteotomy
• Additional relevant MeSH terms: Osteoarthritis; Dwarfism; Remifentanil; Propofol; Desflurane

Study Results

No Results Posted as of Mar 16, 2020