- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922060
Evaluation of Cerebral Venous Return With Internal Jugular Vein Blood Flow in Gynecological Laparoscopic Surgery
The steep Trendelenburg position (STP) provides an advantage in laparoscopic procedures as it optimizes the surgical image. In laparoscopic operations, the need for CO2 pneumoperitoneum (PP), together with this non-physiological position, raises concerns about the patient's physiological homeostasis. Although most patients seem to tolerate the combination of STP and PP, this method carries risks of ICP (intracranial pressure) and brain perfusion. The head-down position increases arterial pressure as well as CVP, thereby disrupting cerebral venous drainage and increasing hydrostatic pressures in the cerebral vascular system. This increases cerebrovascular resistance and decreases cerebral blood flow by increasing ICP and cerebral edema. Systemic CO2 absorption from pneumoperitoneum causes hypercarbia. Hypercarbia can increase cerebral blood flow through cerebral vasodilation.
Seventy-four percent to 95% of cerebral venous drainage in the supine position is provided by IJVs. Studies have shown that IJVs, which are responsible for most cerebral venous drainage, exhibit changes in diameter and blood flow due to TP. These studies were generally conducted on moderate TP and on healthy volunteers. In this study, we aim to evaluate the effects of a steep Trendelenburg position (25°) and pneumoperitoneum on IJV blood flow in patients undergoing operation under general anesthesia
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: emine ASLANLAR
- Phone Number: 05556219830
- Email: draslanlar@gmail.com
Study Contact Backup
- Name: Mehmet SARGIN
- Phone Number: 05322662766
- Email: mehmet21sargin@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
ASA I-II physical status age between 18 and 65 years planned gynecological laparoscopic surgery. -
Exclusion Criteria:
history of head and neck surgery history of cerebrovascular disease ASA III-IV physical status
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in internal jugular vein blood flow in laparoscopic gynecological cases
Time Frame: 90 minute
|
to evaluate the effects of the pneumoperitoneum (PP) and steep Trendelenburg position (STP) on cerebral venous return with internal jugular vein (IJV) blood flow in gynecological laparoscopic surgery
|
90 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: emine ASLANLAR, selcuk univercity medical faculty
Publications and helpful links
General Publications
- 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.
- Yeoh TY, Venkatraghavan L, Fisher JA, Meineri M. Internal jugular vein blood flow in the upright position during external compression and increased central venous pressure: an ultrasound study in healthy volunteers. Can J Anaesth. 2017 Aug;64(8):854-859. doi: 10.1007/s12630-017-0903-3. Epub 2017 Jun 2.
- Uluer MS, Sargin M, Basaran B. Comparison of the effect of the right lateral tilt position and Trendelenburg position on the right internal jugular vein in healthy volunteers: A prospective observational study. J Vasc Access. 2019 Nov;20(6):672-676. doi: 10.1177/1129729819838169. Epub 2019 Apr 12.
- Lee JG, Park HB, Shin HY, Kim JD, Yu SB, Kim DS, Ryu SJ, Kim GH. Effect of Trendelenburg position on right and left internal jugular vein cross-sectional area. Korean J Anesthesiol. 2014 Nov;67(5):305-9. doi: 10.4097/kjae.2014.67.5.305. Epub 2014 Nov 26.
- Terai C, Anada H, Matsushima S, Shimizu S, Okada Y. Effects of mild Trendelenburg on central hemodynamics and internal jugular vein velocity, cross-sectional area, and flow. Am J Emerg Med. 1995 May;13(3):255-8. doi: 10.1016/0735-6757(95)90194-9.
- Marcus HE, Bonkat E, Dagtekin O, Schier R, Petzke F, Wippermann J, Bottiger BW, Teschendorf P. The impact of Trendelenburg position and positive end-expiratory pressure on the internal jugular cross-sectional area. Anesth Analg. 2010 Aug;111(2):432-6. doi: 10.1213/ANE.0b013e3181e2fe41. Epub 2010 May 19.
- Ishida S, Miyati T, Ohno N, Hiratsuka S, Alperin N, Mase M, Gabata T. MRI-based assessment of acute effect of head-down tilt position on intracranial hemodynamics and hydrodynamics. J Magn Reson Imaging. 2018 Feb;47(2):565-571. doi: 10.1002/jmri.25781. Epub 2017 Jun 3.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EASLANLAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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