Assessment of POCD After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen
NCT ID: NCT03372135
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
147 participants
OBSERVATIONAL
2017-01-01
2019-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Incidence of Postoperative Cognitive Decline in Patients With Preexisting Cognitive Impairment
NCT07135336
Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation
NCT01826955
A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery
NCT06334289
Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
NCT01839227
Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)
NCT04837391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Will undergo the robot-assisted radical cystectomy
* informed consent, volunteered to participate in this experiment, ASA I - III
Exclusion Criteria
* 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
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RenJi Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jie Chen
Role: PRINCIPAL_INVESTIGATOR
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YYL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.