Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.

Conditions
-----------------
Anesthesia Awareness

Intervention / Treatment
-----------------
* Procedure: Group TCI
* Procedure: Group TIVA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A will be anesthetized using TIVA, group B using TCI
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group TCI<br>induction and anesthesia will be held by using target-controll infusion | Procedure: Group TCI<br>* 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.<br>|
| Active Comparator: Group TIVA<br>induction and anesthesia will be held by manual dosing of propofol and sufentanil | Procedure: Group TIVA<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of awareness | consciousness during operation | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of haemodynamical instability | reduction of blood pressure by 25 % | 5 hours | 
| reduction of norepinephrine dose | reduction in ugs during the whole operation | 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia Awareness, Dreaming in anesthesia, Total intravenous anesthesia, Target-controll infusion