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Temperature Management on Postoperative Delirium

Effect of Intraoperative Temperature Management on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06406257
Acronym
POD
Enrollment
150
Registered
2024-05-09
Start date
2024-05-20
Completion date
2025-05-01
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Keywords

Postoperative Delirium, Body Temperature, Hyperthermia, Hypothermia

Brief summary

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

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.

Interventions

DEVICE3M™ 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.

Sponsors

The Second Hospital of Anhui Medical University
CollaboratorOTHER
Wang Hongjian
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative deliriumWithin 3 days after surgeryConfusion Assessment Method (CAM) was recorded before surgery, 10 min after admission to PACU, before exiting the post-anesthesia care unit (PACU), and 1, 2, and 3 days after surgery. POD was diagnosed if the patient had at least one episode of delirium at these time points after surgery. The CAM diagnostic algorithm is based on four cardinal features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.

Secondary

MeasureTime frameDescription
Incidence of intraoperative hypothermiaDuring operationPerioperative hypothermia was defined as a drop in core temperature below 36 ℃. Intraoperative tympanic membrane temperature was measured to record the incidence and duration of hypothermia.
Pleiotropic cytokine in the patient's serumSerum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.Clinical trials and meta-analyses have identified the association between POD and increased perioperative levels of Interleukin-6 (IL-6), a pleiotropic cytokine that is both necessary and sufficient for postoperative memory decline in a preclinical model of POD.

Contacts

Primary ContactHongjian Wang, MD
wanghj_a@163.com+86 15806019263

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026