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

NCT02826902 | Completed

• 1 other identifier: 4-2016-0164
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Stature; Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• QoR-40 score

  24 hours after surgery

Secondary Outcomes (1)

• QoR-40 score

  preoperative period to 48 hours after surgery

Study Arms (2)

TIVA group

ACTIVE COMPARATOR

Drug: propofol and remifentanil

Inhalation anesthesia group

ACTIVE COMPARATOR

Drug: desflurane and remifentanil

Interventions

propofol and remifentanil DRUG

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

TIVA group

desflurane and remifentanil DRUG

Anesthesia is induced and maintained with desflurane and remifentanil

Inhalation anesthesia group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient refusal
• Patients with altered mental status
• Ejection fraction under 55%
• Recent MI, CVA, or major cardiovascular surgery
• rd 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Dwarfism; Osteoarthritis

Interventions

Propofol; Remifentanil; Desflurane

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: September 27, 2016
• Primary Completion: November 9, 2019
• Study Completion: November 9, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)