NCT06318351

Brief Summary

Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
476

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

March 12, 2024

Last Update Submit

April 6, 2024

Conditions

Keywords

DeliriumThoracoscopic lung resection surgery

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Mini-Mental State Examination, MMSE

    7days

Secondary Outcomes (1)

  • Recovery

    7days

Study Arms (1)

Transcutaneous Electrical Acupoint Stimulation

The effect of Transcutaneous Electrical Acupoint Stimulation on postoperative vision was observed according to anesthesiologist's habit of using or not using it.

Procedure: transcutaneous acupoint electrical stimulation

Interventions

This is a safe and non-invasive procedure, similar to an electrode sheet, which applies a weak current to a specific site to achieve the purpose of acupoint stimulation.

Transcutaneous Electrical Acupoint Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing thoracoscopic pneumonectomy

You may qualify if:

  • Voluntary participation in the study;
  • Age ≥ 18 years;
  • Patients scheduled for thoracoscopic lung resection surgery;
  • ASA grade I-III.

You may not qualify if:

  • History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
  • History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
  • Severe cardiovascular and cerebrovascular diseases;
  • Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
  • Pregnant or postpartum women;
  • Patients with language communication barriers;
  • Deemed unsuitable for participation by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Emergence DeliriumDelirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Qin Zhang, phd

    Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

February 1, 2024

Primary Completion

December 30, 2024

Study Completion

August 30, 2025

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations