Temperature Management on Postoperative Delirium

Emergence Delirium Clinical Trial

— POD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406257
• Other study ID #: 2024-keyan-045
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: Second People's Hospital of Hefei City
• Contact: Hongjian Wang, MD
• Phone: +86 15806019263
• Email: wanghj_a[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wang Hongjian	The Second Hospital of Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	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.	Within 3 days after surgery
Secondary	Incidence of intraoperative hypothermia	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.	During operation
Secondary	Pleiotropic cytokine in the patient's serum	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.	Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.