Intracranial Pressure Increase Clinical Trial
Official title:
Comparison of the Effects of Extraperitoneal and Transperitoneal Laparoscopic Surgeries on Intracranial Pressure: A Prospective Clinical Study
Verified date | March 2023 |
Source | Konya City Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
When the literature is examined, it has been reported in many studies that intracranial pressure increases due to laparoscopic procedures performed in the intraperitoneal area. The mechanism of increased intracranial pressure (ICP) associated with insufflation is most likely due to impaired venous drainage of the lumbar venous plexus at increased intra-abdominal pressure. Changes in ICP can be monitored by ultrasonographic measurement of optic nerve sheath diameter (ONSD), which is a generally accepted simple, reliable and non-invasive ICP measurement technique. In meta-analyses conducted on this subject, it has been revealed that ICP elevation during laparoscopy can be observed with a significant increase in ONSD in the early (0 30 minutes) and late (30-120 minutes) periods during carbondioxid (CO2) pneumoperitoneum. However, the effect of laparoscopic procedures performed in the extraperitoneal area on the central nervous system is not clear. There is not found any study in the literature comparing laparoscopic procedures, especially performed extraperitoneally and transperitoneally, and their effects on intracranial pressure. The aim of the study compare to laparoscopic cholecystectomy performed in the transperitoneal area and (totally extra-peritoneal) TEP inguinal hernia repair performed in the extraperitoneal area in terms of intracranial pressure relationship.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 20, 2023 |
Est. primary completion date | January 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 18-70 years old, - ASA (American Society of Anesthesiologists) I-II, - patients who will undergo laparoscopic cholecystectomy with the diagnosis of symptomatic cholelithiasis or TEP due to inguinal hernia. Exclusion Criteria: - patients who were switched to open surgery, - glaucoma, corneal disease, eye surgery, - cerebrovascular disease, - any neurological disease, - chronic kidney disease, - liver cirrhosis, - patients whose peritoneum was opened during TEP. |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Health Science Konya City Hospital | Konya |
Lead Sponsor | Collaborator |
---|---|
Konya City Hospital |
Turkey,
Citerio G, Vascotto E, Villa F, Celotti S, Pesenti A. Induced abdominal compartment syndrome increases intracranial pressure in neurotrauma patients: a prospective study. Crit Care Med. 2001 Jul;29(7):1466-71. doi: 10.1097/00003246-200107000-00027. — View Citation
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. — View Citation
Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18. — View Citation
Montorfano L, Giambartolomei G, Funes DR, Lo Menzo E, Dip F, White KP, Rosenthal RJ. The Cushing reflex and the vasopressin-mediated hemodynamic response to increased intracranial pressure during acute elevations in intraabdominal pressure. Surgery. 2020 Feb;167(2):478-483. doi: 10.1016/j.surg.2019.10.006. Epub 2019 Dec 6. — View Citation
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. doi: 10.1093/bja/aew356. — View Citation
Rosenthal RJ, Friedman RL, Chidambaram A, Khan AM, Martz J, Shi Q, Nussbaum M. Effects of hyperventilation and hypoventilation on PaCO2 and intracranial pressure during acute elevations of intraabdominal pressure with CO2 pneumoperitoneum: large animal observations. J Am Coll Surg. 1998 Jul;187(1):32-8. doi: 10.1016/s1072-7515(98)00126-4. — View Citation
Rosenthal RJ, Hiatt JR, Phillips EH, Hewitt W, Demetriou AA, Grode M. Intracranial pressure. Effects of pneumoperitoneum in a large-animal model. Surg Endosc. 1997 Apr;11(4):376-80. doi: 10.1007/s004649900367. — View Citation
Steiner CA, Karaca Z, Moore BJ, Imshaug MC, Pickens G. Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014. 2017 May [updated 2020 Jul 20]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #223. Available from http://www.ncbi.nlm.nih.gov/books/NBK442035/ — View Citation
Yashwashi T, Kaman L, Kajal K, Dahiya D, Gupta A, Meena SC, Singh K, Reddy A. Effects of low- and high-pressure carbon dioxide pneumoperitoneum on intracranial pressure during laparoscopic cholecystectomy. Surg Endosc. 2020 Oct;34(10):4369-4373. doi: 10.1007/s00464-019-07207-w. Epub 2019 Oct 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | measurements of optic nerve sheath diameter (ONSD) | mm | during surgery | |
Secondary | heart rate value | /min | during surgery | |
Secondary | blood pressure | mmHg | during surgery | |
Secondary | SPO2 measurements | during surgery | ||
Secondary | ETCO2 measurements | mmHg | during surgery |
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