NCT04224532 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R
Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.
Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M
Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791.
Sahay N, Sharma S, Bhadani UK, Singh A, Sinha C, Sahay A, Ranjan A, Agarwal M
Effect of Pneumoperitoneum and Patient Positioning on Intracranial Pressures during Laparoscopy: A Prospective Comparative Study. J Minim Invasive Gynecol. 2018 Jan;25(1):147-152. doi: 10.1016/j.jmig.2017.07.031. Epub 2017 Sep 12.

The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopic Cholecystectomy: Before or After Reverse Trendelenburg Position

Clinical trial NCT04224532 - References