Scheme of Limb Warming Blanket Combined With Dexmedetomidine

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857410
• Other study ID #: JinchengGH001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 25, 2023

Study information

• Verified date: May 2023
• Source: Jincheng General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 25, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Chills
• Delirium
• Spine Surgery

Intervention

Drug:
• Dexmetomidine
Dexmetomidine (H20183219) 0.4µg / (kg·min);

Device:
• Lower limb heating blanket
Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.

Locations

Country	Name	City	State
China	Jincheng General Hospital	Jincheng	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jincheng General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative vital signs monitoring	nasopharyngeal temperature	1 hour
Primary	Intraoperative vital signs monitoring	nasopharyngeal temperature	2 hour
Primary	Intraoperative vital signs monitoring	nasopharyngeal temperature	3 hour
Primary	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
Primary	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
Primary	Postoperative extubation time	The recovery time from the end of surgery to extubation was recorded.	1 hour
Primary	Postoperative incision infection rate	The incidence of postoperative incision infection was recorded.	1 hour