Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2018
CompletedStudy Start
First participant enrolled
March 16, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedMay 10, 2024
May 1, 2024
7.8 years
March 9, 2018
May 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction of awareness
consciousness during operation
5 hours
Secondary Outcomes (2)
reduction of haemodynamical instability
5 hours
reduction of norepinephrine dose
5 hours
Study Arms (2)
Group TCI
EXPERIMENTALinduction and anesthesia will be held by using target-controll infusion
Group TIVA
ACTIVE COMPARATORinduction and anesthesia will be held by manual dosing of propofol and sufentanil
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Glasgow Coma scale 15
- ASA Physical Status Classification System I - III
- planed surgery for brain tumor to 5 hours
- postoperative awakening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pavel Dostal, MD, Ph.D.
University Hospital Hradec Kralove
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2018
First Posted
March 23, 2018
Study Start
March 16, 2018
Primary Completion
December 15, 2025
Study Completion (Estimated)
June 30, 2027
Last Updated
May 10, 2024
Record last verified: 2024-05