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Completed

NCT Number: NCT02813044

Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor

A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they have limitations especially for the phase of recovery after anesthesia: a fragmentary assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to assess the degree of recovery, specially after anesthesia and surgery. In this study, the investigators aim to compare the quality of recovery after inhalational anesthesia and after TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for pituitary tumor under general anesthesia.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Associate Professor Department of Anesthesiology and Pain Medicine,

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over age 19
  • Scheduled to undergo transsphenoidal surgery for pituitary tumor
  • ASA class I and II

Exclusion criteria

  • Left ventricular ejection fraction < 55%
  • Third-degree atrioventricular block
  • Second-degree atrioventricular block (P:QRS ratio of 3:1 or higher)
  • Fever
  • History of myocardial infarction, stroke or cardiac surgery within the previous 1 year
  • Severe neurological disease
  • Use of sedative, opioid or sleep-inducing drugs
  • Allergic history of any study drug
  • Pregnancy

Treatment and study plan

Total intravenous anesthesia (TIVA)

Drug

In the TIVA group,anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil.

inhalation anesthesia group

Drug

In the inhalation anesthesia group, anesthesia is induced by pentothal sodium 4-6mg/kg and remifentanil 1 μg/kg, and then maintained with end-tidal sevoflurane concentration of 0.8 to 1 MAC and continuous infusion of remifentanil at 0.1-0.3μg/kg/min.

Primary outcomes

  1. QoR-40 score

    Time frame: 1 day

    We compare the QoR-40 scores of two groups 1 day after the operation.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Sep 29, 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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