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.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03476213

Enrollment

Registered

2018-03-23

Start date

2018-03-16

Completion date

2027-06-30

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Awareness

Keywords

Anesthesia Awareness, Dreaming in anesthesia, Total intravenous anesthesia, Target-controll infusion

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.

Interventions

PROCEDUREGroup 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.

PROCEDUREGroup 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Group A will be anesthetized using TIVA, group B using TCI

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
reduction of awareness	5 hours	consciousness during operation

Secondary

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

Countries

Czechia

Contacts

Primary ContactVlasta Dostalova, MD. Ph.D.

vlasta.dostalova@fnhk.cz+420777883571

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026