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Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia

Completed
Conditions
Pituitary Tumor
Interventions
Procedure: Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)
Registration Number
NCT03465423
Lead Sponsor
Yonsei University
Brief Summary

Investigators hypothesized that propofol dose for pituitary somatotroph patients might differ from nonfunctioning pituitary tumor, and investigators will evaluate a target controlled infusion (TCI) effect site concentration (Ce) of propofol for BIS score of 40 and LOC (loss of consciousness) in pituitary somatotroph patients in comparison with non functioning pituitary tumor patients.

On arrival in the operating room, standard monitoring devices, including electrocardiogram, pulse oximetry, noninvasive blood pressure cuff, and bispectral index (BIS) will be applied to the patients. Propofol with the modified Marsh pharmacokinetic parameters using a keo of 1.2/min will be administered through TCI pump (OrchestraBase Primea, Fresenius Vial, France). The initial target Ce of propofol will be chosen as 3.0 mg/mL (0.5 mg/mL of incremental size) based on an earlier study.

The sedation of patients will be assessed with BIS score and the modified observer's assessment of awareness and sedation (OAA/S). LOC was defined as an OAA/S lower than 2 (loss of response to spoken command to eye opening and loss of response to mild prodding or shaking). The primary end point of this study is the Ce of propofol when the BIS score is 40. The secondary end point of this study is the Ce of propofol at LOC.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
62
Inclusion Criteria
  • patients with pituitary somatotroph tumor and with nonfunctioning pituitary tumor in transsphenoidal pituitary surgery
  • American society of anesthesiologists classification 1 or 2
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Exclusion Criteria
  • left ventricle ejection fraction < 55% 3RD degree AV block, 2nd degree AV block with P:QRS > 3:1
  • serum Creatinine > 1.0mg/dl
  • myocardial infarction or cerebral stroke in 1 yrs
  • fever > 38C
  • dementia, cognitive disorder, confused mental status
  • pregnant patients
  • allergic to propofol
  • illiteracy or foreigners
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
patients with nonfunctioning pituitary tumorNot applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)patients with nonfunctioning pituitary tumor undergoing transsphenoidal pituitary surgery under total intravenous anesthesia
patients with pituitary somatotroph tumorNot applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)patients with pituitary somatotroph tumor undergoing transsphenoidal pituitary surgery under total intravenous anesthesia
Primary Outcome Measures
NameTimeMethod
effect site concentration of propofol5 minutes after subject's anesthesia induction

Investigators will assess the propofol requirement in pituitary tumor patients during the induction of general anesthesia when subject's BIS (Bispectral Index Score) is 40

Secondary Outcome Measures
NameTimeMethod
effect site concentration of propofol2 minutes after subject's anesthesia induction

Investigators will assess the propofol requirement in pituitary tumor patients during the induction of general anesthesia when the pituitary tumor patients lose their consciousness.

Trial Locations

Locations (1)

Associate Professor Department of Anesthesiology and Pain Medicine

🇰🇷

Seoul, Korea, Republic of

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