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Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG MonitoringTandRTNCT07670689

Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG Monitoring

A study testing Bispectral index monitoring in people with Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG Monitoring, run by Cukurova University at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to evaluate the effects of processed electroencephalogram (pEEG) monitoring on recovery and extubation times, length of stay in the post-anesthesia care unit (PACU), postoperative pain, patient comfort, sedation, development of delirium, and length of hospital and intensive care unit stay in… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bispectral index monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
3 sitesTurkey (Türkiye)
Study dates
27 Jul 2026to 12 Oct 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients aged 18-75 yr, classified as American Society of Anesthesiologists (ASA) physical status I-II, and scheduled for elective laparoscopic abdominal surgery with an anticipated duration of at least 1 h

Who cannot join

  • if they had a history of neuropsychiatric disorders, neuromuscular disease, severe cardiovascular or respiratory disease, upper respiratory tract infection within the preceding 14 days, body mass index (BMI) >40 kg m-², alcohol or substance abuse, previous bronchospasm, anticipated difficult tracheal intubation, previous tracheostomy, laryngeal disease or surgery, ASA physical status ≥III, or an actual surgical duration of less than 1 h

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites
  • Cukurova University

    Adana, Adana, 01330

  • Çukurova Üniversitesi, Tıp Fakültesi, Anesteziyoloji AD. 01130 Sarıçam, ADANA

    Adana, Adana, 01330

  • Çukurova Üniversitesi, Tıp Fakültesi, Anesteziyoloji AD. 01130 Sarıçam, ADANA

    Sariçam, Adana, 01330

Other trials in Turkey (Türkiye)

About this study

Official title: Recovery, Analgesia And Delirium Profiles At Laparoscopic Surgeries With Processed EEG Monitoring: Comparison Of Trendelenburg And Reverse-Trendelenburg Positions

The aim of this study is to evaluate the effects of processed electroencephalogram (pEEG) monitoring on recovery and extubation times, length of stay in the post-anesthesia care unit (PACU), postoperative pain, patient comfort, sedation, development of delirium, and length of hospital and intensive care unit stay in laparoscopic surgeries performed in the Trendelenburg (T) or reverse Trendelenburg (RT) positions.

Materials and Methods: This prospective, randomized, single-center study included a total of 136 patients will be scheduled for elective laparoscopic surgery under general anesthesia. Patients will allocated into four groups according to surgical position (Group T or Group RT) and the use of processed electroencephalogram monitoring (Group TBIS and Group RTBIS). Intraoperative depth of anesthesia will be maintained either by titration guided by processed electroencephalogram indices or according to standard clinical parameters. Extubation time, recovery time, length of stay in the PACU, postoperative pain scores, patient comfort, level of sedation, incidence of delirium, and lengths of hospital and intensive care unit stay will be recorded.

Read the detailed description

A total of 136 adult patients aged 18-75 yr, classified as American Society of Anesthesiologists (ASA) physical status I-II, and scheduled for elective laparoscopic abdominal surgery with an anticipated duration of at least 1 h will be included.

Patients will be excluded if they had a history of neuropsychiatric disorders, neuromuscular disease, severe cardiovascular or respiratory disease, upper respiratory tract infection within the preceding 14 days, body mass index (BMI) >40 kg m-², alcohol or substance abuse, previous bronchospasm, anticipated difficult tracheal intubation, previous tracheostomy, laryngeal disease or surgery, ASA physical status ≥III, or an actual surgical duration of less than 1 h.

Randomization and Study Groups

Patients will be randomly allocated to one of four study groups according to surgical position and use of processed electroencephalographic monitoring:

Group TBIS: Trendelenburg position with BIS monitoring. Group T: Trendelenburg position without BIS monitoring. Group RTBIS: Reverse Trendelenburg position with BIS monitoring. Group RT: Reverse Trendelenburg position without BIS monitoring. Computer-generated randomization was used for group allocation.

Haemodynamic and respiratory variables, including systolic and diastolic arterial pressure, SpO₂, ETCO₂, peak airway pressure, and BIS values, will be recorded before and after positioning in the Trendelenburg or reverse Trendelenburg position.

Demographic and perioperative data, including age, sex, height, weight, type of surgery, duration of surgery, and duration of anaesthesia, will be collected.

Extubation and recovery times, total desflurane consumption and cumulative EEG suppression time will be recorded for all patients.

PACU discharge time, pain intensity (VAS score), cumulative morphine consumption, additional analgesic (meperidine) requirements, patient comfort, and haemodynamic variables will be assessed at 15, 30, and 60 min after PACU admission.

Delirium screening will ve performed before induction of anaesthesia, at PACU admission, at PACU discharge, and twice daily thereafter (08:00 and 20:00) from postoperative day 1 through postoperative day 3, or until hospital discharge if discharge occurred earlier. Postoperative adverse events, including nausea and vomiting, respiratory depression, bradycardia, hypotension, hypertension, shivering, and urinary incontinence, will be recorded. Intensive care unit (ICU) admission, ICU length of stay, and total hospital length of stay will also be documented.

Being tested
Bispectral index monitoring
Keywords
Processed EEG; Laparoscopic surgery; Recovery; Delirium; Depth of anesthesia
Medical subject headings
Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bispectral index monitoringDevice

    Group TBIS: Trendelenburg position with BIS monitoring. Group T: Trendelenburg position without BIS monitoring. Group RTBIS: Reverse Trendelenburg position with BIS monitoring. Group RT: Reverse Trendelenburg position without BIS monitoring.

Study groups in NCT07670689
Study groupRoleWhat they receive
Group TBISActive comparatorTrendelenburg position with BIS monitoring
Receives: Device: Bispectral index monitoring
Group TNo interventionTrendelenburg position without BIS monitoring
Group RTBISActive comparatorReverse Trendelenburg position with BIS monitoring
Receives: Device: Bispectral index monitoring
Group RTNo interventionReverse Trendelenburg position without BIS monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shorter recovery times following surgery

    The primary hypothesis was that routine pEEG monitoring would be associated with shorter recovery times following surgery

    Measured: From enrollment to the end of the study at 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2026
  2. Study start27 Jul 2026
  3. Primary completion1 Oct 2026
  4. Study completion12 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Patients with the present study was designed to compare the effects of pEEG-guided anaesthesia with standard anaesthetic management without pEEG monitoring on postoperative recovery and clinical outcomes in patients undergoing laparoscopic surgery in the Trendelenburg or reverse Trendelenburg position. We hypothesized that pEEG-guided anaesthetic titration would reduce unnecessary anaesthetic exposure and facilitate faster postoperative recovery. The primary hypothesis was that routine pEEG monitoring would be associated with shorter recovery times following surgery. Secondary objectives included assessment of extubation time, PACU discharge time, postoperative pain intensity, patient comfort, sedation level, incidence of postoperative delirium, adverse events, intensive care unit admission, and intensive care unit length of stay.
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07670689
Sponsor's protocol ID
Decision Number: 157
Acronym
TandRT
Status last verified
Oct 2026
First submitted
22 Jun 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: "Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared. This will include the Statistical Analysis Plan (SAP). Data will be made available to researchers who provide a methodologically sound proposal, solely to achieve aims in the approved proposal. Proposals should be directed to \[hunlugenc@gmail.com\]."

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