- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07670689
Recovery, Analgesia And Delirium Profiles At Laparoscopic Abdominal and Gynecologic Surgeries With Processed EEG Monitoring (TandRT)
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hakkı NA Ünlügenç, professor
- Telefonnummer: +90 3223386742 +905336417891
- E-post: unlugenc@cu.edu.tr
Studera Kontakt Backup
- Namn: Zuhal Ünlügenç, MD
- Telefonnummer: +905323960620
- E-post: zunlugenc@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group TBIS
Trendelenburg position with BIS 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.
|
|
Inget ingripande: Group T
Trendelenburg position without BIS monitoring
|
|
|
Aktiv komparator: Group RTBIS
Reverse Trendelenburg position with BIS 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.
|
|
Inget ingripande: Group RT
Reverse Trendelenburg position without BIS monitoring
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Shorter recovery times following surgery
Tidsram: From enrollment to the end of the study at 5 months
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: HAKKI NA UNLUGENC, Professör, Cukurova University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Decision Number: 157
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
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