Pneumoperitoneum, Trendelenburg Position
Conditions
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.
Interventions
PROCEDURELaparoscopic Surgery
Laparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position
Sponsors
Reuven Pizov
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Delirium | Within 7 days after surgery | As assessed by CAM-ICU |
Countries
Israel
Contacts
Primary ContactReuven Pizov, MD
Outcome results
None listed