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

• ClinicalTrials.gov Identifier: NCT03372135
• Recruitment Status: Unknown
• First Posted: December 13, 2017
• Last Update Posted: April 17, 2018
• Sponsor: RenJi Hospital
• Information provided by (Responsible Party): RenJi Hospital

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

China, Shanghai

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai, China, 200126

Sponsors and Collaborators

RenJi Hospital

Investigators

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

More Information

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. Review.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT03372135 History of Changes
• Other Study ID Numbers: YYL
• First Posted: December 13, 2017
• Last Update Posted: April 17, 2018
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Pneumoperitoneum; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Peritoneal Diseases; Digestive System Diseases