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

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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery; Postoperative Delirium and Chills
• Intervention / Treatment: Device: Lower limb heating blanket; Drug: Dexmetomidine

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Jincheng, Shanxi, China, 048006
      • Jincheng General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jincheng General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Elderly spinal surgery; Delirium and chills
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Chills
• Other Study ID Numbers: JinchengGH001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No