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Scheme of Limb Warming Blanket Combined With Dexmedetomidine

Clinical Effect Observation of Lower Limb Warming Blanket Combined With Dexmedetomidine in Preventing Postoperative Delirium and Chills in Elderly Patients Undergoing Spinal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05857410
Enrollment
160
Registered
2023-05-12
Start date
2019-01-01
Completion date
2023-01-25
Last updated
2023-05-12

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

Conditions

Postoperative Delirium and Chills, Spine Surgery

Keywords

Elderly spinal surgery, Delirium and chills

Brief summary

Objective: To observe the clinical effect of lower limb warming blanket combined with dexmedetomidine (DEX) in preventing postoperative delirium (POD) and chills in elderly patients undergoing spinal surgery. Methods: A total of 160 elderly patients undergoing posterior spinal surgery under general anesthesia were selected and divided into control group (group N), heating group (group T), DEX group (group D) and heating combined with DEX group (group TD) according to the random number table method, 40 cases in each group. T group and TD group routine insulation and lower limb heating blanket. DEX was injected in group D and group TD. The dosage of anesthetics, the changes of body temperature and heart rate at different time points during operation, and the occurrence of postoperative chills and POD were compared among the groups.

Interventions

DRUGDexmetomidine

Dexmetomidine (H20183219) 0.4μg / (kg·min);

DEVICELower limb heating blanket

Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.

Sponsors

Jincheng General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age: between 65-80 years old; * American Society of Anesthesiologists (ASA) grade II-III; * Normal body temperature before operation; * the operation time was 2-4 hours

Exclusion criteria

* Preoperative fever or hypothermia (body temperature≥37.5 ℃ or≤35.5℃ on the day of operation); * Body mass index (BMI) \>30 kg/m2; * The existence of heart, brain, lung, kidney and other important organs and circulatory system, respiratory system, immune system, central nervous system diseases; * Patients who had taken antipsychotic drugs or β-blockers before surgery would have a greater impact on intraoperative body temperature and other patients who could not effectively cooperate with this study; * Patients with operation time more than 5 hours

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative vital signs monitoring1 hournasopharyngeal temperature
The incidence of postoperative chills1 hourchills refer to the Wrench classification criteria as follows : 0: no chills; grade 1: peripheral vascular contraction, vertical hair, but no muscle fibrillation; level 2: only one muscle group had muscle fibrillation; grade 3: muscle fibrillation in multiple groups; level 4: general tremor; ≥ 1 level was judged to have chills.
The incidence of POD after operation1 dayThe results of POD in each group were recorded, and the POD was evaluated by CAM-CR scale. The incidence of POD at 24,48 and 72 h after operation was compared among the groups
Postoperative extubation time1 hourThe recovery time from the end of surgery to extubation was recorded.
Postoperative incision infection rate1 hourThe incidence of postoperative incision infection was recorded.

Countries

China

Outcome results

None listed

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