Clinical trial NCT06685159: Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position
Official title: Risk Factors for Postoperative Complications in Surgery With Pneumoperitoneum in Trendelenburg Position. Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trendelenburg Position
Pneumoperitoneum
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who undergo elective laparoscopic surgery in the Hadassah Ein-Kerem Medical Center

Brief summary: Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.


Eligibility criteria: Inclusion Criteria:

* ASA Class I-IV.
* Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.
* Planned arterial catheter insertion.

Exclusion Criteria:

* Pregnancy.
* Planned open abdominal surgery.
* Renal Replacement Therapy.

Primary outcomes:
measure: Perioperative change in urine NGAL
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Acute Kidney Injury
timeFrame: 2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.
measure: Perioperative change in serum NGAL
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in serum concentration of Cannabidiol
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery
measure: Perioperatitve change in urine concentration of Cannabidiol
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in TBW
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in ECW
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in serum pH
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in serum BE
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in serum lactate concentration
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
measure: Perioperatitve change in serum syndecan-1 concentration
timeFrame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery
Secondary outcomes:
measure: Delirium
timeFrame: Within 7 days after surgery
measure: CVA / TIA
timeFrame: Within 30 days after surgery
measure: Myocardial Ischemia
timeFrame: During hospital stay, within 30 days after surgery
measure: Arrhythmia
timeFrame: During hospital stay, within 30 days after surgery
measure: Atelectasis
timeFrame: During hospital stay, within 30 days after surgery
measure: Pneumonia
timeFrame: During hospital stay, within 30 days after surgery
measure: ARDS
timeFrame: During hospital stay, within 30 days after surgery
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalaim
Study officials:
References: