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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03465423
Other study ID # 4-2017-1241
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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