NCT07797660

Brief Summary

Postoperative delirium is a common acute central nervous system syndrome, which often occurs 1-5 days after surgery. Postoperative delirium can prolong the length of hospital stay, increase the mortality rate, and is also associated with long-term postoperative cognitive dysfunction. However, the pathogenesis of postoperative delirium in elderly patients undergoing neurosurgical procedures, who are at high risk for ostoperative delirium, remains unclear. This study aims to elucidate the underlying mechanisms of postoperative delirium in this population and inform the development of effective prevention and treatment strategies.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Aug 2026Sep 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 30, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 26, 2026

Last Update Submit

August 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The association between intraoperative hypotension and postoperative delirium

    Intraoperative hypotension was defined by absolute mean arterial pressure (MAP) thresholds (sustained MAP \< 75, 70, 65, or 60 mm Hg for \> 1 min) or relative MAP reductions (10%, 20%, 30%, or 40% below preoperative baseline). The Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) or 3 min diagnostic interview for CAM (3D-CAM) will be applied to assess postoperative delirium.

    The surgery day and twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days.

Secondary Outcomes (3)

  • Characteristic of electroencephalogram

    The surgery day

  • Regional cerebral oxygen saturation changes

    The surgery day

  • Blood inflammatory factors

    The surgery day

Study Arms (2)

Intraoperative hypotension

Without intraoperative hypotension

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will be selected from elderly patients scheduled to undergo elective craniotomy for intracranial tumour resection at Beijing Tiantan Hospital.

You may qualify if:

  • Patients undergoing elective craniotomy for intracranial tumour resection
  • Patients who will provide written informed consent

You may not qualify if:

  • Patients with severe preoperative cognitive impairment precluding subsequent assessments
  • History of psychotropic medication use
  • Previous history of neurosurgical operation
  • Severe bradycardia (heart rate \< 40 beats per minute)
  • Sick-sinus syndrome or atrioventricular block of grade Ⅱ or above
  • Severe hepatic insufficiency (Child-Pugh grade C)
  • Renal failure requiring renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

DeliriumBrain Neoplasms

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Yuming Peng, M.D., Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief of Department of Anesthesiology

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 1, 2026

Study Start

August 30, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations