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

Not Applicable

Recruiting

• Conditions: Anesthesia Awareness
• Interventions: Procedure: Group TIVA; Procedure: Group TCI

• Registration Number: NCT03476213
• Lead Sponsor: University Hospital Hradec Kralove

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.

Study Timeline

• Study First Submitted: 2018-03-09
• Study Start: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-12-15
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TIVA	Group TIVA	induction and anesthesia will be held by manual dosing of propofol and sufentanil
Group TCI	Group TCI	induction and anesthesia will be held by using target-controll infusion

Primary Outcome Measures

Name	Time	Method
reduction of awareness	5 hours	consciousness during operation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia