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Clinical Trials/NCT03372135
NCT03372135
Completed
N/A

Postoperative Cognitive Deficit After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen: A Prospective Observational Pilot Study

RenJi Hospital1 site in 1 country147 target enrollmentJanuary 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Cognitive Dysfunction
Sponsor
RenJi Hospital
Enrollment
147
Locations
1
Primary Endpoint
Diagnosis of postoperative cognitive dysfunction
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
November 6, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • The effect of steep Trendelenburg position and CO2 Pneumoperitoneum on POCD(1 year)
  • Probable risk factors of POCD(1 year)

Study Sites (1)

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