Relationship Between Induction Burst Suppression and Bispectral Index

NCT07557433 | Not Yet Recruiting

• 1 other identifier: 2026-82
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Burst Suppression; Bispectral Index Monitoring; Total Intravenous Anesthesia

Outcome Measures

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

  During intraoperative period

Secondary Outcomes (8)

• TBIS40-60

  During intraoperative period

• TBIS>60

  During intraoperative period

• TLOC

  During induction of anesthesia

• BIS-LOC

  At the exact time of loss of consciousness (LOC)

• TROC

  During emergence from anesthesia

Study Arms (2)

Burst Suppression Group

Patients who exhibited burst suppression during the anesthesia induction period, defined as a burst suppression ratio of ≥10% lasting for at least 1 minute

Non-Burst Suppression Group

Patients who did not exhibit burst suppression during the anesthesia induction period, defined as the absence of burst suppression with a burst suppression ratio ≥10% lasting for at least 1 minute

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A tertiary care center in Amasya, Turkey

You may qualify if:

• 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)

You may not qualify if:

• Presence of neurological disease
• Chronic use of sedative medications or antiepileptic drugs
• Severe hepatic or renal dysfunction
• Intraoperative administration of ketamine or dexmedetomidine

Sponsors & Collaborators

• Amasya University: lead

Study Sites (2)

Amasya University Sabuncuoglu Serefeddin Training and Research Hospital

Amasya, Amasya, 05200, Turkey (Türkiye)

Location

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, İzmir, 35360, Turkey (Türkiye)

Location

Central Study Contacts

Bülent Meriç Çam, MD

CONTACT

+90 (534) 815 6011; bulentmericcam@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TU (2)