Clinical trial NCT03465423: Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia
Official title: Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators hypothesized that propofol dose for pituitary somatotroph patients might differ from nonfunctioning pituitary tumor, and we 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.

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.


Eligibility criteria: Inclusion Criteria:

* patients with pituitary somatotroph tumor and with nonfunctioning pituitary tumor in transsphenoidal pituitary surgery
* American society of anesthesiologists classification 1 or 2

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

Primary outcomes:
measure: effect site concentration of propofol
timeFrame: 5 minutes after subject's anesthesia induction
Secondary outcomes:
measure: effect site concentration of propofol
timeFrame: 2 minutes after subject's anesthesia induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Associate Professor Department of Anesthesiology and Pain Medicine
Study officials:
References: