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Completed

NCT Number: NCT02826902

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

propofol and remifentanil

Drug

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

desflurane and remifentanil

Drug

Anesthesia is induced and maintained with desflurane and remifentanil

Primary outcomes

  1. QoR-40 score

    Time frame: 24 hours after surgery

Secondary outcomes

  1. QoR-40 score

    Time frame: preoperative period to 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2016
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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