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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

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ClinicalTrials.gov Identifier: NCT02813044
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : January 10, 2019
Sponsor:
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

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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

Drug Information available for: Sevoflurane

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT02813044


Locations
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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    csho99@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02813044     History of Changes
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:
anesthesia
intravenous
neurosurgery
pituitary neoplasm
postoperative period
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Remifentanil
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors