Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group TCI, Group TIVA.
- Who it may be relevant to
- Registry conditions: Anesthesia Awareness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
Overview
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.
Interventions
- 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. - Procedure 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.
Primary outcome measures
- reduction of awareness [Time frame: 5 hours]
Secondary outcome measures (2)
- reduction of haemodynamical instability [Time frame: 5 hours]
- reduction of norepinephrine dose [Time frame: 5 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Czechia · 1 center
- University Hospital Hradec Kralove — Hradec Králové
Identifiers
NCT: NCT03476213 · 201506S