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NCT Number: NCT07557433

Relationship Between Induction Burst Suppression and Bispectral Index

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.

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Key information

Conditions

Bispectral Index Monitoring Burst Suppression Total Intravenous Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amasya University Sabuncuoglu Serefeddin Training and Research Hospital, Amasya, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. TBIS<40

    Time frame: During intraoperative period

    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

Secondary outcomes

  1. TBIS40-60

    Time frame: During intraoperative period

    Duration during maintenance anesthesia in which BIS values remain between 40 and 60, expressed as a proportion of total surgical time.

  2. TBIS>60

    Time frame: During intraoperative period

    Duration during maintenance anesthesia in which BIS remains above 60, expressed as a proportion of total surgical time.

  3. TLOC

    Time frame: During induction of anesthesia

    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.

  4. BIS-LOC

    Time frame: At the exact time of loss of consciousness (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

  5. TROC

    Time frame: During emergence from anesthesia

    Time to return of consciousness:Time from discontinuation of anesthetic agents during the maintenance phase of anesthesia to return of consciousness. Return of consciousness was defined as the moment when the patient regained consciousness, demonstrated by eye opening and/or response to verbal commands, and the time was recorded in seconds

  6. BIS-ROC

    Time frame: At the moment of response to verbal commands during emergence from anesthesia

    Bispectral Index (BIS) value at the timeof return of consciousness. Return of consciousness was defined as the moment when the patient responded to verbal commands.

  7. Propofol infusion rate during anesthesia

    Time frame: During the intraoperative period

    Propofol administration will be recorded at 1-minute intervals throughout the intraoperative period. Additionally, total drug consumption during the procedure will be obtained from infusion pump records. Values recorded at 1-minute intervals will be used for time-based correlation analyses, while infusion pump data will be used to calculate mean infusion rates. The total amount of propofol administered during the entire surgical procedure will be calculated and expressed as mg/kg/hour.

  8. Remifentanil infusion rate during anesthesia

    Time frame: During the intraoperative period

    Remifentanil administration will be recorded at 1-minute intervals throughout the intraoperative period. Additionally, total drug consumption during the procedure will be obtained from infusion pump records. Values recorded at 1-minute intervals will be used for time-based correlation analyses, while infusion pump data will be used to calculate mean infusion rates. The total amount of remifentanil administered during the entire surgical procedure will be calculated and expressed as µg/kg/min

Study contacts

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

Bülent Meriç Çam, MD

CONTACT

[email protected]

+90 (534) 815 6011

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study title

The Relationship Between Burst Suppression Observed During Anesthesia Induction and the Bispectral Index Value During the Maintenance Phase of Anesthesia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Jul 6, 2026

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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