CompletedNot Applicable

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

South Korea62 participantsStarted 2018-03-20

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

effect site concentration of propofol

Timeframe: 5 minutes after subject's anesthesia induction

Trial details

NCT IDNCT03465423

SponsorYonsei University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12-04

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