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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
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
Postoperative cognitive decline (POCD) is a common and impactful outcome of surgical procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly understood. 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, 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. 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.

Condition or disease
Postoperative Cognitive Dysfunction

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort
Trendelenburg group
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.
Control group
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Chinese
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study choose Chinese patients(ASA I - III

) above the age of 55, who will recently undergo the robot-assisted radical cystectomy. All those patients should be informed consent and be volunteered to participate in this experiment.

Those audio and visual impairment, illiteracy,existing severe central nervous system disease, patients with central nervous system disease or surgery which resulted in severe sequelae, alcohol dependence, usage of psychotropic medications, reoperative MMSE score was less than 24 should be excluded.

Criteria

Inclusion Criteria:

  • Above age of 55
  • Will undergo the robot-assisted radical cystectomy
  • informed consent, volunteered to participate in this experiment, ASA I - III

Exclusion Criteria:

  • Audio and visual impairment, illiteracy
  • Existing severe central nervous system disease
  • Patients with central nervous system disease or surgery , resulted in severe sequelae
  • Alcohol dependence
  • Take psychotropic medications
  • Preoperative MMSE score was less than 24

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200126
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Jie Chen Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03372135     History of Changes
Other Study ID Numbers: YYL
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
POCD
RARC
Trendelenburg Position
Additional relevant MeSH terms:
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Pneumoperitoneum
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Peritoneal Diseases
Digestive System Diseases