An observational study in Postoperative Cognitive Dysfunction, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by RenJi Hospital · Observational
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Among 57 studies in Postoperative Cognitive Complications with a site in China — 14 open to participants now, 16 under way, none of them phase 3. Postoperative Cognitive Complications · China.
Among the 57 studies in Postoperative Cognitive Complications with a site in China, this one is the 15th largest by enrollment of the 24 observational ones that give a count, is one of 2 that started in 2017, is one of 24 observational ones, and was the 16th registered.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
Browse Postoperative Cognitive Complications studies →14 of the 57 studies in Postoperative Cognitive Complications with a site in China are open now. Recruiting first, the newest first:
Shanghai Geriatric Medical Center · Sites in China
Ages 65+
Peking University Shenzhen Hospital · Sites in China
Ages 60+ · Healthy volunteers
Zhuan Zhang · Sites in China
Ages 18+
West China Hospital · Sites in China
Ages 65–90 · Healthy volunteers
Nanjing First Hospital, Nanjing Medical University · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 34 Postoperative Cognitive Complications studies recruiting now, 22 (65%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 2 · Phase 4 10
First in 2012; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 147 is above the median of 100 across 113 observational studies indexed under Postoperative Cognitive Complications.
Median enrollment 220 across the 33 interventional studies, 213 across the 24 observational. Of the 17 that completed or were terminated, 1 (6%) have results posted.
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1 of 57 have an industry lead sponsor. The 10 most frequent:
RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
RenJi Hospital has 8 studies filed under Postoperative Cognitive Complications — fewer than ten, so there is no comparison to draw.
5 of the studies in Postoperative Cognitive Complications with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07643194Beijing Anzhen HospitalCohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting | 2026-11-24 |
| NCT07673978The Second Affiliated Hospital of Chongqing Medical UniversityEffect of Ciprofol Injection on Postoperative Cognitive Function | 2026-12-30 |
| NCT07135336Peking University Shenzhen HospitalIncidence of Postoperative Cognitive Decline in Patients With Preexisting Cognitive Impairment | 2027-01-01 |
| NCT05555693Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityCorrelation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients | 2027-01-01 |
| NCT07895407Second Affiliated Hospital of Wenzhou Medical UniversityEffects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery | 2027-03-01 |
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Among the 57 studies in Postoperative Cognitive Complications with a site in China, from their registry updates:
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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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Time frame: One week after surgery
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.
Time frame: 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.
Time frame: 1 year
Plan to share: Undecided
Ran from Jan 2017 to primary completion in May 2018, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Postoperative Cognitive Complications →