COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02813044
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pituitary Tumor Drug: total intravenous anesthesia (TIVA) Drug: inhalation anesthesia group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TIVA group
Anesthesia is maintained with propofol during surgery
Drug: total intravenous anesthesia (TIVA)
In the TIVA group,anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil.

Active Comparator: inhalation anesthesia group
Anesthesia is maintained with sevoflurane during surgery
Drug: inhalation anesthesia group
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 Outcome Measures :
  1. QoR-40 score [ Time Frame: 1 day ]
    We compare the QoR-40 scores of two groups 1 day after the operation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02813044

Layout table for location information
Korea, Republic of
Associate Professor Department of Anesthesiology and Pain Medicine, Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Seung Ho Cho, Ph.D    82-2-2228-2427   
Sponsors and Collaborators
Yonsei University
Layout table for additonal information
Responsible Party: Yonsei University Identifier: NCT02813044    
Other Study ID Numbers: 4-2016-0344
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
pituitary neoplasm
postoperative period
Additional relevant MeSH terms:
Layout table for MeSH terms
Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Central Nervous System Depressants
Physiological Effects of Drugs