Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position

Recruiting

• Conditions: Trendelenburg Position; Pneumoperitoneum

• Registration Number: NCT06685159
• Lead Sponsor: Reuven Pizov

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-19
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-06-19
• Study Completion: 2026-06-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative change in serum NGAL	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample
Perioperatitve change in serum concentration of Cannabidiol	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery	Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample
Perioperative change in urine NGAL	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Acute Kidney Injury	2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.	According to the KDIGO acute renal injury stage
Perioperatitve change in urine concentration of Cannabidiol	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Perioperatitve change in TBW	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Perioperative change in the bioimpedence-based measurement of Total Body Water (TBW)
Perioperatitve change in ECW	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Perioperative change in the bioimpedence-based measurement of Extracellular Water (ECW)
Perioperatitve change in serum pH	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	As measured by arterial blood gas
Perioperatitve change in serum BE	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Perioperatitve change in serum Base Excess (BE) As measured by arterial blood gas
Perioperatitve change in serum lactate concentration	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Perioperatitve change in serum lactate concentration as measured by arterial blood gas
Perioperatitve change in serum syndecan-1 concentration	Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery	Measured by ELISA

Secondary Outcome Measures

Name	Time	Method
Delirium	Within 7 days after surgery	As assessed by CAM-ICU
CVA / TIA	Within 30 days after surgery	New diagnosis of cerebrovascular accident or transient ischemic attack
Myocardial Ischemia	During hospital stay, within 30 days after surgery	New myocardial ischemia, as diagnosed by ecg or serum troponin
Arrhythmia	During hospital stay, within 30 days after surgery	New clinically significant arrhythmia
Atelectasis	During hospital stay, within 30 days after surgery	New atelectasis
Pneumonia	During hospital stay, within 30 days after surgery	According to CDC criteria
ARDS	During hospital stay, within 30 days after surgery	New Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Yerushalaim, Israel