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NCT Number: NCT03476213

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

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.

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Key information

Conditions

Anesthesia Awareness Intraoperative Awareness Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group TCI

Procedure

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

Procedure

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.

Primary outcomes

  1. reduction of awareness

    Time frame: 5 hours

    consciousness during operation

Secondary outcomes

  1. reduction of haemodynamical instability

    Time frame: 5 hours

    reduction of blood pressure by 25 %

  2. reduction of norepinephrine dose

    Time frame: 5 hours

    reduction in ugs during the whole operation

Study contacts

Contact information is provided by the study sponsor or research team.

Vlasta Dostalova, MD. Ph.D.

CONTACT

[email protected]

+420777883571

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2027
First posted
Mar 23, 2018
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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