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

Sponsor

University Hospital Hradec Kralove (Other)

Overall Status

Recruiting

CT.gov ID

NCT03476213

Collaborator

(none)

Enrollment

Location

Arms

63.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Awareness	Procedure: Group TCI Procedure: Group TIVA	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 16, 2018

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group TCI induction and anesthesia will be held by using target-controll infusion	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.
Active Comparator: Group TIVA induction and anesthesia will be held by manual dosing of propofol and sufentanil	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Group TCI

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

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.

Active Comparator: Group TIVA

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

reduction of awareness [5 hours]
consciousness during operation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove		Czechia	50005

Sponsors and Collaborators

University Hospital Hradec Kralove

Investigators

Study Director: Pavel Dostal, MD, Ph.D., University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dostalova Vlasta, MD, PhD, Principal Investigator, University Hospital Hradec Kralove

ClinicalTrials.gov Identifier:

NCT03476213

Other Study ID Numbers:

201506S

First Posted:

Mar 23, 2018

Last Update Posted:

Feb 15, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dostalova Vlasta, MD, PhD, Principal Investigator, University Hospital Hradec Kralove

Anesthesia Awareness

Dreaming in anesthesia

Total intravenous anesthesia

Target-controll infusion

Additional relevant MeSH terms:

Intraoperative Awareness

Study Results

No Results Posted as of Feb 15, 2022