Assessment of POCD After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200126
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of postoperative cognitive dysfunction	Using Z score method to analyse and comprehensively evaluate cognitive dysfunction scale which can help diagnosing the incidence of POCD.	One week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probable risk factors of POCD	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.	1 year
The effect of steep Trendelenburg position and CO2 Pneumoperitoneum on POCD	Comparison of morbidity is made between patients underwent RARC and those who have taken surgery in horizontal position.	1 year

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jie Chen, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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.
• Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.
• Ding LL, Zhang H, Mi WD, Liu J, Jin CH, Yuan WX, Liu Y, Ni LY, Bo LL, Deng XM. [Anesthesia management of laparoscopic radical cystectomy and orthotopic bladder surgery with a robotic-assisted surgical system]. Beijing Da Xue Xue Bao Yi Xue Ban. 2013 Oct 18;45(5):819-22. Chinese.
• Li Y, Huang D, Su D, Chen J, Yang L. Postoperative cognitive dysfunction after robot-assisted radical cystectomy (RARC) with cerebral oxygen monitoring an observational prospective cohort pilot study. BMC Anesthesiol. 2019 Nov 6;19(1):202. doi: 10.1186/s12871-019-0877-5.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): November 6, 2019

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: POCD; Trendelenburg Position; RARC
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Pneumoperitoneum; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: YYL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No