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

NCT ID: NCT02826902

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2019-11-09

Brief Summary

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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.

Detailed Description

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Conditions

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Short Stature Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TIVA group

Group Type ACTIVE_COMPARATOR

propofol and remifentanil

Intervention Type DRUG

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

Inhalation anesthesia group

Group Type ACTIVE_COMPARATOR

desflurane and remifentanil

Intervention Type DRUG

Anesthesia is induced and maintained with desflurane and remifentanil

Interventions

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propofol and remifentanil

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

Intervention Type DRUG

desflurane and remifentanil

Anesthesia is induced and maintained with desflurane and remifentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2016-0164

Identifier Type: -

Identifier Source: org_study_id

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