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).
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
- Conditions the study is for
- Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG Monitoring
- 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
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 group | Role | What they receive |
|---|---|---|
| Group TBIS | Active comparator | Trendelenburg position with BIS monitoring Receives: Device: Bispectral index monitoring |
| Group T | No intervention | Trendelenburg position without BIS monitoring |
| Group RTBIS | Active comparator | Reverse Trendelenburg position with BIS monitoring Receives: Device: Bispectral index monitoring |
| Group RT | No intervention | Reverse Trendelenburg position without BIS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted26 Jun 2026
- Study start27 Jul 2026
- Primary completion1 Oct 2026
- Study completion12 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakki Unlugenc, Cukurova University
- Investigators
- HAKKI UNLUGENC, Professör, Study director, Cukurova University
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 \[hunlugenc@gmail.com\]."