Scheme of Limb Warming Blanket Combined With Dexmedetomidine

Study Overview
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Brief Summary
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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.

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

Conditions
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Spine Surgery, Postoperative Delirium and Chills

Intervention / Treatment
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* Drug: Dexmetomidine
* Device: Lower limb heating blanket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group (group N)<br> | |
| Active Comparator: heating group (group T)<br> | Device: Lower limb heating blanket<br>* Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.<br>|
| Active Comparator: DEX group (group D)<br> | Drug: Dexmetomidine<br>* Dexmetomidine (H20183219) 0.4μg / (kg·min)；<br>|
| Experimental: heating combined with DEX group (group TD)<br> | Drug: Dexmetomidine<br>* Dexmetomidine (H20183219) 0.4μg / (kg·min)；<br>Device: Lower limb heating blanket<br>* Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative vital signs monitoring | nasopharyngeal temperature | 1 hour | 
| Intraoperative vital signs monitoring | nasopharyngeal temperature | 2 hour | 
| Intraoperative vital signs monitoring | nasopharyngeal temperature | 3 hour | 
| The incidence of postoperative chills | chills 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. | 1 hour | 
| The incidence of POD after operation | The 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 | 1 day | 
| Postoperative extubation time | The recovery time from the end of surgery to extubation was recorded. | 1 hour | 
| Postoperative incision infection rate | The incidence of postoperative incision infection was recorded. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly spinal surgery, Delirium and chills