ClinicalTrials.gg
Status unknownNCT03393676Updated Mar 10, 2020

Preoperative Pain and POCD in Elderly Patients

An observational study in Postoperative Cognitive Dysfunction, sponsored by RenJi Hospital. Status unknown at 2 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

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.

Planned enrollment
19th of 24
100 · median 213
Started
2018
with 3 others
Observational
24 of 57
7 open now
Registered
17th of 57
by date
Lead sponsor
8 of 57
RenJi Hospital

Among the 57 studies in Postoperative Cognitive Complications with a site in China, this one is the 19th largest by planned enrollment of the 24 observational ones that give a count, is one of 4 that started in 2018, is one of 24 observational ones, and was the 17th registered.

Postoperative Cognitive Complications

260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.

Browse Postoperative Cognitive Complications studies →

Open to participants now

14 of the 57 studies in Postoperative Cognitive Complications with a site in China are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

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 →

Who these studies take

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: 65 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.

Read the detailed description

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.

03

Conditions studied

  • Postoperative Cognitive Dysfunction

Keywords

  • Postoperative Cognitive Dysfunction
  • elderly patients
  • Preoperative Pain
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Elderly patients underwent elective low limb surgery(hemiarthroplasty or total hip arthroplasty); Chronic pain duration >3 months.

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.

Inclusion criteria

  1. Elder than 65 years old
  2. Speak Chinese Mandarin
  3. Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
  4. Signed the inform consent
  5. classification I to II

Exclusion criteria

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
  2. Existing cognitive impairment as evidenced by scores below 24
  3. Severe hearing or visual impairment
  4. Unwillingness to comply with the protocol or procedures
  5. Cannot communicate with Chinese Mandarin
  6. Serious pulmonary, heart , liver or renal insufficiency patients
  7. Had anesthesia or surgery within the past 30 days
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. POCD incidence 7 days (or before leaving hospital) after surgery

    POCD incidence 7 days (or before leaving hospital) after surgery

    Time frame: 7 days (or before leaving hospital)

Secondary outcomes

  1. POCD incidence 2 months after surgery

    POCD incidence 2 months after surgery

    Time frame: 2 months after surgery

07

Study locations

2 of 2 sites recruiting
  • Reni Hospital, Shanghai Jiao Tong University, School of Medicine
    Shanghai, Shanghai 200127, China
    Recruiting
  • Shanghai Ren ji Hospital
    Shanghai, Shanghai 200127, China
    Recruiting
08

References and documents

Publications

  • Huai X, Jiao Y, Gu X, Zhu H, Chen L, Fan Y, Yu W, Su D, Xie H. Preoperative Chronic Pain as a Risk Factor for Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: A Prospective Observational Cohort Study. Front Neurosci. 2021 Dec 17;15:747362. doi: 10.3389/fnins.2021.747362. eCollection 2021. PubMed 34975369 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Mar 2020, 26 months after the start.

Of 76 non-industry observational studies under Postoperative Cognitive Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's planned 26 months is close to that.

Counting every sponsor, half of 76 studies reached it within 27 months; a quarter within 11 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2017
First posted
Jan 8, 2018
StartActual
Jan 10, 2018
Primary completionEst.
Mar 31, 2020
CompletionEst.
Mar 31, 2020
Last update
Mar 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03393676
Lead sponsor
RenJi Hospital
Responsible party
Xiaorong Huai (Dr., RenJi Hospital) — Principal investigator
First posted
Jan 8, 2018
Start date
Jan 10, 2018
Primary completion
Mar 31, 2020 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
Mar 10, 2020

Study contacts

Xiaorong Huai, MS
Contact
smile_huai@126.com
13818003683
Diansan Su, MD
Contact
diansansu@yahoo.com
18616514088
Weifeng Yu, MD
study chair · Anesthesiology Department Renji Hospital, Shanghai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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