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
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 |
Verified date | February 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Associate Professor Department of Anesthesiology and Pain Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04529356 -
The TMS Treatment for Postoperative Headache in GH Tumor
|
N/A | |
Completed |
NCT03363126 -
Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma
|
N/A | |
Completed |
NCT04212793 -
Detection of PitNET Tissue During TSS Using Bevacizumab-800CW
|
Phase 1 | |
Recruiting |
NCT03309319 -
A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
|
N/A | |
Terminated |
NCT04106531 -
Validation of a Quality of Life Metric "Prolac-10"
|
||
Recruiting |
NCT03719781 -
Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
|
||
Recruiting |
NCT01556230 -
Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
|
||
Recruiting |
NCT03132259 -
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
|
Phase 4 | |
Recruiting |
NCT01368133 -
The Observational Study of Growth Hormone-secreting Pituitary Tumors
|
N/A | |
Withdrawn |
NCT04863339 -
Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
|
Phase 2 | |
Terminated |
NCT00646308 -
Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas
|
N/A | |
Recruiting |
NCT00852501 -
Characterization of Receptors in Non-functioning Pituitary Macroadenomas
|
Phase 4 | |
Recruiting |
NCT03474601 -
Seoul National University Pituitary Disease Cohort Study
|
||
Recruiting |
NCT05139277 -
Evaluation of the CONVIVO System
|
N/A | |
Active, not recruiting |
NCT03636568 -
Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)
|
N/A | |
Completed |
NCT02813044 -
Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor
|
N/A | |
Recruiting |
NCT03973450 -
Epidemiology of Pituitary Tumours: Prevalence of Associated Neoplasia
|
||
Active, not recruiting |
NCT04042753 -
Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors
|
Phase 2 | |
Recruiting |
NCT04018963 -
The Impact of Endoscopic Pituitary Surgery on Nasal Function
|
||
Not yet recruiting |
NCT04938401 -
Construction and Application of a Risk Prediction Model Forepistaxis After Pituitary Tumor Resection
|