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

Anesthesia Awareness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03476213
• Other study ID #: 201506S
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: University Hospital Hradec Kralove
• Contact: Vlasta Dostalova, MD. Ph.D.
• Phone: +420777883571
• Email: vlasta.dostalova[@]fnhk.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2027
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Awareness
• Intraoperative Awareness

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of awareness	consciousness during operation	5 hours
Secondary	reduction of haemodynamical instability	reduction of blood pressure by 25 %	5 hours
Secondary	reduction of norepinephrine dose	reduction in ugs during the whole operation	5 hours