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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07670689
Acronym
TandRT
Enrollment
136
Registered
2026-06-26
Start date
2026-07-27
Completion date
2027-01-15
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Processed EEG; Laparoscopic surgery; Recovery; Delirium; Depth of anesthesia

Brief 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 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.

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.

Interventions

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.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Shorter recovery times following surgeryFrom enrollment to the end of the study at 5 monthsThe primary hypothesis was that routine pEEG monitoring would be associated with shorter recovery times following surgery

Contacts

CONTACTHakkı NA Ünlügenç, professor
unlugenc@cu.edu.tr+905336417891
CONTACTZuhal Ünlügenç, MD
zunlugenc@gmail.com+905323960620
STUDY_DIRECTORHAKKI NA UNLUGENC, Professör

Cukurova University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026