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OpenTrials
Completed

NCT Number: NCT03465423

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

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)

Procedure

The patients of two cohort group will undergo general anesthesia in the same way and therefore there is no intervention in this study.

Primary outcomes

  1. effect site concentration of propofol

    Time frame: 5 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 outcomes

  1. effect site concentration of propofol

    Time frame: 2 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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