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

University Hospital Hradec Kralove

Status: Enrolling

Conditions: Anesthesia Awareness

Treatments: Procedure: Group TCI; Procedure: Group TIVA

Study type: Interventional

Funder types: Other

Identifiers

NCT03476213

201506S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Group TCI

Experimental group

Description:

induction and anesthesia will be held by using target-controll infusion

Treatment:

Procedure: Group TCI

Group TIVA

Active Comparator group

Description:

induction and anesthesia will be held by manual dosing of propofol and sufentanil

Treatment:

Procedure: Group TIVA