Relationship Between Induction Burst Suppression and Bispectral Index
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAmasya University
About this trial
The purpose of this study is to understand whether certain brain activity patterns that can appear at the beginning of anesthesia are related to how deep anesthesia remains during the operation.
The main question of the study is:
Do patients who show a pattern called burst suppression during the start of anesthesia experience deeper anesthesia during surgery?
Patients who are scheduled for elective surgery under total intravenous anesthesia (TIVA) may take part in this study. During the operation, brain activity will be monitored using a sensor placed on the forehead (Bispectral Index, BIS monitor), which is already commonly used during anesthesia. Information such as BIS values and the doses of anesthesia medications given during the operation will be recorded.
Participation in this study will not change the type of anesthesia or the routine care that patients receive during surgery. The study only involves recording and analyzing information collected during standard anesthesia monitoring.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
American Society of Anesthesiologists (ASA) physical status I-III
Scheduled for elective surgery
Surgery planned to be performed under total intravenous anesthesia (TIVA)
Disqualifiers
Presence of neurological disease
Chronic use of sedative medications or antiepileptic drugs
Severe hepatic or renal dysfunction
Intraoperative administration of ketamine or dexmedetomidine
Trial population
A tertiary care center in Amasya, Turkey
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Burst Suppression Group
Group B: Non-Burst Suppression Group
Trial outcomes
Primary outcomes
1
TBIS<40
Total duration during the maintenance phase of anesthesia in which the BIS remains below 40, expressed as a proportion of total surgical time, compared between patients with and without burst suppression during induction
Time frame
During intraoperative periodSecondary outcomes
1
TBIS40-60
Duration during maintenance anesthesia in which BIS values remain between 40 and 60, expressed as a proportion of total surgical time.
Time frame
During intraoperative period2
TBIS>60
Duration during maintenance anesthesia in which BIS remains above 60, expressed as a proportion of total surgical time.
Time frame
During intraoperative period3
TLOC
Time to loss of consciousness :Time from induction agent administration to loss of consciousness. Loss of consciousness is defined as the moment when both the eyelash and corneal reflexes are abolished, and the time was recorded in seconds.
Time frame
During induction of anesthesia4
BIS-LOC
Bispectral Index (BIS) value at the time of loss of consciousness following induction of anesthesia. Loss of consciousness is defined as the moment when both the eyelash and corneal reflexes are abolished
Time frame
At the exact time of loss of consciousness (LOC)Sponsors and contacts
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Source ClinicalTrials.gov