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

NCT03465423 | Completed

• 1 other identifier: 4-2017-1241
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor

Outcome Measures

Primary Outcomes (1)

• effect site concentration of propofol

  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

  5 minutes after subject's anesthesia induction

Secondary Outcomes (1)

• effect site concentration of propofol

  2 minutes after subject's anesthesia induction

Study Arms (2)

patients with nonfunctioning pituitary tumor

patients with nonfunctioning pituitary tumor undergoing transsphenoidal pituitary surgery under total intravenous anesthesia

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

patients with pituitary somatotroph tumor

patients with pituitary somatotroph tumor undergoing transsphenoidal pituitary surgery under total intravenous anesthesia

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

Interventions

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.

patients with nonfunctioning pituitary tumor; patients with pituitary somatotroph tumor

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Associate Professor Department of Anesthesiology and Pain Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 14, 2018
• Study Start: March 20, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)