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

NCT07670689 | Not Yet Recruiting

• 1 other identifier: Decision Number: 157
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Shorter recovery times following surgery

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

  From enrollment to the end of the study at 5 months

Study Arms (4)

Group TBIS

ACTIVE COMPARATOR

Trendelenburg position with BIS monitoring

Device: Bispectral index monitoring

Group T

NO INTERVENTION

Trendelenburg position without BIS monitoring

Group RTBIS

ACTIVE COMPARATOR

Reverse Trendelenburg position with BIS monitoring

Device: Bispectral index monitoring

Group RT

NO INTERVENTION

Reverse Trendelenburg position without BIS monitoring

Interventions

Bispectral index monitoring DEVICE

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.

Group RTBIS; Group TBIS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Related Links

• Joseph A, Theerth KA, Karipparambath V, Palliyil A. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure and cerebral blood flow assessed using transcranial doppler: A prospective observational study. J Anaesthesiol Clin Pharma

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• HAKKI NA UNLUGENC, Professör

  Cukurova University

  STUDY DIRECTOR

Central Study Contacts

Hakkı NA Ünlügenç, professor

CONTACT

+905336417891; unlugenc@cu.edu.tr

Zuhal Ünlügenç, MD

CONTACT

+905323960620; zunlugenc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor, MD

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months and ending 36 months after article publication
• Access Criteria: Data will be shared with qualified researchers whose proposed use has been approved by an independent review committee