The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy
NCT ID: NCT04224532
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
79 participants
INTERVENTIONAL
2020-01-08
2020-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressure Ranges (10-12 mmHg and 13- 15 mmHg ) on Cerebral Oxygenation (With a Non-invasive Technique, Near Infrared Spectroscopy (NIRS) ) in Laparoscopic Cholecystectomy
NCT04309318
The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies
NCT07274488
Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
NCT05992636
Quality of Recovery Under Low or Standard Pneumoperitoneum Pressure
NCT05040022
Comparison of Coagulation Factors During Laparoscopic Cholecystectomy
NCT02568852
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group P
Pneumoperitoneum is induced before reverse Trendelenburg position.
Pneumoperitoneum Timing (Before Positioning)
Before Reverse Trendelenburg Position
Group RT
Pneumoperitoneum is induced after reverse Trendelenburg position.
Pneumoperitoneum Timing (After Positioning)
After Reverse Trendelenburg Position
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pneumoperitoneum Timing (Before Positioning)
Before Reverse Trendelenburg Position
Pneumoperitoneum Timing (After Positioning)
After Reverse Trendelenburg Position
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18-65
* ASA I-II
* BMI ≤ 35
Exclusion Criteria
* Increased intracranial pressure
* History of cerebrovascular disease
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bagcilar Training and Research Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Serdar Demirgan, MD
Role: PRINCIPAL_INVESTIGATOR
Bagcilar Training and Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bagcilar Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Demirgan S, Ozcan FG, Gemici EK, Guneyli HC, Yavuz E, Gulcicek OB, Selcan A. Reverse Trendelenburg position applied prior to pneumoperitoneum prevents excessive increase in optic nerve sheath diameter in laparoscopic cholecystectomy: randomized controlled trial. J Clin Monit Comput. 2021 Feb;35(1):89-99. doi: 10.1007/s10877-020-00608-6. Epub 2020 Oct 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019.10.103.072
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.