Clinical trial

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

Name
JinchengGH001
Description
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.
Trial arms
Trial start
2019-01-01
Estimated PCD
2022-12-30
Trial end
2023-01-25
Status
Completed
Treatment
Dexmetomidine
Dexmetomidine (H20183219) 0.4μg / (kg·min);
Arms:
DEX group (group D), heating combined with DEX group (group TD)
Lower limb heating blanket
Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.
Arms:
heating combined with DEX group (group TD), heating group (group T)
Size
160
Primary endpoint
Intraoperative vital signs monitoring
1 hour
Intraoperative vital signs monitoring
2 hour
Intraoperative vital signs monitoring
3 hour
The incidence of postoperative chills
1 hour
The incidence of POD after operation
1 day
Postoperative extubation time
1 hour
Postoperative incision infection rate
1 hour
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}
Updated at
2023-05-12

1 organization

1 product

2 indications

Indication
Spinal Surgery