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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03476213
Other study ID # 201506S
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2018
Est. completion date June 30, 2027

Study information

Verified date May 2024
Source University Hospital Hradec Kralove
Contact Vlasta Dostalova, MD. Ph.D.
Phone +420777883571
Email vlasta.dostalova@fnhk.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.


Description:

Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 30, 2027
Est. primary completion date December 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Glasgow Coma scale 15 - ASA Physical Status Classification System I - III - planed surgery for brain tumor to 5 hours - postoperative awakening Exclusion Criteria: - NYHA III, IV - abuse of stimulating drugs, grass, alcohol dependence - BMI over 40 in females and over 35 in men - propofol alergie - awake operations - postoperative arteficial ventilation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Group TCI
Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.
Group TIVA
Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction of awareness consciousness during operation 5 hours
Secondary reduction of haemodynamical instability reduction of blood pressure by 25 % 5 hours
Secondary reduction of norepinephrine dose reduction in ugs during the whole operation 5 hours
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