Low Pressure Pneumoperitoneum and Postoperative Ileus

NANot yet recruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

July 31, 2027

Conditions
Postoperative IleusGastrointestinal Dysfunction
Interventions
PROCEDURE

Pneumoperitoneum Pressure

"Low Pneumoperitoneum Pressure: defined as an intrabdominal pressure between 8-12 mmHg during the laparoscopic procedure.~High Pneumoperitoneum pressure: defined as an intrabdominal pressure of 15 mmHg or more during the laparoscopic procedure.~Note: surgeons will set the pneumoperitoneum at the lowest value they are comfortable with based on their surgical criteria"

PROCEDURE

Neuromuscular blockade

"Moderate neuromuscular blockade: defined as the presence of 1 or 2 responses after train-of-four stimulation.~Deep neuromuscular blockade: defined as no response to train-of-four stimulation and 1 or less responses after post-tetanic count stimulation."

DEVICE

Pneumoperitoneum insufflation device

"AirSeal® device or Olympus standard of care insufflation device. Both devices are approved for use in laparoscopic gastrointestinal surgeries."

DRUG

Neuromuscular blockade reversal

"Neostigmine: for Arm 1 only (standard use).~Sugammadex: will be used for the other arms in the study.~All drugs used in our randomized trial (neuromuscular blockade with rocuronium and reversal with neostigmine or sugammadex) are standard of care and approved for use by our institutional Institutional Review Board (IRB) Ethics Committee for this trial."

Trial Locations (2)

43210

The Ohio State University Wexner Medical Center, Columbus

Tzagournis Medical Research Facility, Columbus

All Listed Sponsors
lead

Ohio State University

OTHER

NCT05344417 - Low Pressure Pneumoperitoneum and Postoperative Ileus | Biotech Hunter | Biotech Hunter