Assessment of POCD After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen
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|ClinicalTrials.gov Identifier: NCT03372135|
Recruitment Status : Unknown
Verified October 2017 by RenJi Hospital.
Recruitment status was: Enrolling by invitation
First Posted : December 13, 2017
Last Update Posted : April 17, 2018
|Condition or disease|
|Postoperative Cognitive Dysfunction|
Postoperative cognitive decline (POCD) is a short-term decline in cognitive function (especially in memory and executive functions) that may last from a few days to a few weeks after surgery. It is a common and impactful outcome of surgical procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly understood. It is supposed to be associated with numerous factors such as ages, trauma, inflammation, surgical stress, position, fluid, MBP, artificial pneumoperitoneum , PCO2, FiO2.
The robot-assisted radical cystectomy (RARC) is increasingly utilized. In patients undergoing RARC, Although prolonged Trendelenburg position and pneumoperitoneum can increase the cerebral blood flow, there were studies showed that the excessive cerebral perfusion can lead to encephalemia, which reduce the oxygen uptake of brain tissue and cause insufficient oxygenation of brain tissue at the cellular level. POCD may take place due to cerebral hemodynamic changes. Contemporary, intraoperative fluid restriction, a relatively long time of operation and surgical stress may also contribute to POCD.
The goal of the current study is to investigate the combined effect of this position and CO2 pneumoperitoneum on POCD during RARC with the monitor of cerebral oxygen.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Postoperative Cognitive Deficit After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen: A Prospective Observational Pilot Study|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||July 1, 2018|
Patients in trendelenburg group take trendelenburg position and have CO2 pneumoperitoneum. Cerebral oxygen monitor will be needed. Take notes per hour for HR, MAP, CVP, SpO2, SrO2 and etCO2.Preoperative and postoperative ABG, S-100beta , CRP and cognitive dysfunction scales will be tested.
Patients in control group take horizontal position. Cerebral oxygen monitor will be needed. Take notes per hour for HR, MAP, CVP, SpO2, SrO2 and etCO2.Preoperative and postoperative ABG, S-100beta , CRP and cognitive dysfunction scales will be tested
- Diagnosis of postoperative cognitive dysfunction [ Time Frame: One week after surgery ]Using Z score method to analyse and comprehensively evaluate cognitive dysfunction scale which can help diagnosing the incidence of POCD.
- Probable risk factors of POCD [ Time Frame: 1 year ]Diagnose and screen out patients with POCD and then analyse probable factors such as MAP, CVP, trendelenburg position etc as assesed by hierarchical regression analysis.
- The effect of steep Trendelenburg position and CO2 Pneumoperitoneum on POCD [ Time Frame: 1 year ]Comparison of morbidity is made between patients underwent RARC and those who have taken surgery in horizontal position.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372135
|Renji Hospital, School of Medicine, Shanghai Jiao Tong University|
|Shanghai, Shanghai, China, 200126|
|Principal Investigator:||Jie Chen||Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University|