Temperature Management on Postoperative Delirium

NCT ID: NCT06406257

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-05-01

Brief Summary

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Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

Detailed Description

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At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.

Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrolled participants were randomly assigned to a control group (Group C) or a body temperature protection group (Group W) in a 1:1 ratio.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group C

Patients in Group C will be covered with a bedsheet intraoperatively without active warming methods employed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group W

Patients in Group W will have a 37°C forced-air warming blanket initiated upon entering the operating room to maintain their body temperature between 36-37 degrees Celsius.

Group Type EXPERIMENTAL

3M™ Bair Hugger™ Warming Unit

Intervention Type DEVICE

Utilizing the 3M Temperature Management Unit to ensure intraoperative body temperature of elderly hip surgery patients remains consistent with their preoperative baseline, while patients in Group C receive no intervention.

Interventions

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3M™ Bair Hugger™ Warming Unit

Utilizing the 3M Temperature Management Unit to ensure intraoperative body temperature of elderly hip surgery patients remains consistent with their preoperative baseline, while patients in Group C receive no intervention.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 65 years
* Classified as American Society of Anesthesiologists I-III
* Hip surgery patients who agreed to the study

Exclusion Criteria

* Non-consent to participate
* Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
* Coma, dementia, or language impairment affecting communication and assessment
* History of neurosurgery
* Use of antipsychotic medication preoperatively
* Body temperature exceeding 38°C within 24 hours before surgery.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Wang Hongjian

OTHER

Sponsor Role lead

Responsible Party

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Wang Hongjian

Attending doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xianwen Hu, PhD

Role: STUDY_CHAIR

The Second Hospital of Anhui Medical University

Central Contacts

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Hongjian Wang, MD

Role: CONTACT

+86 15806019263

Other Identifiers

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2024-keyan-045

Identifier Type: -

Identifier Source: org_study_id

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