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

Pituitary Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465423
• Other study ID #: 4-2017-1241
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: December 4, 2018

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Procedure:
• Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)
The patients of two cohort group will undergo general anesthesia in the same way and therefore there is no intervention in this study.

Locations

Country	Name	City	State
Korea, Republic of	Associate Professor Department of Anesthesiology and Pain Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	effect site concentration of propofol	Investigators will assess the propofol requirement in pituitary tumor patients during the induction of general anesthesia when the pituitary tumor patients lose their consciousness.	2 minutes after subject's anesthesia induction