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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCukurova University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

136 Participants
are divided into 4 treatment groups
Group A: Group TBISActive comparator 1 intervention
Group B: Group TNo intervention 0 interventions
Group C: Group RTBISActive comparator 1 intervention
Group D: Group RTNo intervention 0 interventions

Trial outcomes

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

Time frame
From enrollment to the end of the study at 5 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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