Temperature Management on Postoperative Delirium

Not Applicable

Not yet recruiting

• Conditions: Emergence Delirium
• Interventions: Device: 3M™ Bair Hugger™ Warming Unit

• Registration Number: NCT06406257
• Lead Sponsor: Wang Hongjian

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Study Start: 2024-05-20
• Primary Completion: 2025-02-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group W	3M™ Bair Hugger™ Warming Unit	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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	Within 3 days after surgery	Confusion 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 Outcome Measures

Name	Time	Method
Incidence of intraoperative hypothermia	During operation	Perioperative 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 serum	Serum 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.