Back to resultsScheme of Limb Warming Blanket Combined With Dexmedetomidine
Primary Purpose
Spine Surgery, Postoperative Delirium and Chills
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmetomidine
Lower limb heating blanket
Sponsored by
About this trial
This is an interventional prevention trial for Spine Surgery focused on measuring Elderly spinal surgery, Delirium and chills
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
Sites / Locations
- Jincheng General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Experimental
Arm Label
control group (group N)
heating group (group T)
DEX group (group D)
heating combined with DEX group (group TD)
Arm Description
Outcomes
Primary Outcome Measures
Intraoperative vital signs monitoring
nasopharyngeal temperature
Intraoperative vital signs monitoring
nasopharyngeal temperature
Intraoperative vital signs monitoring
nasopharyngeal temperature
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.
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
Postoperative extubation time
The recovery time from the end of surgery to extubation was recorded.
Postoperative incision infection rate
The incidence of postoperative incision infection was recorded.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05857410
Brief Title
Scheme of Limb Warming Blanket Combined With Dexmedetomidine
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jincheng General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Surgery, Postoperative Delirium and Chills
Keywords
Elderly spinal surgery, Delirium and chills
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group (group N)
Arm Type
No Intervention
Arm Title
heating group (group T)
Arm Type
Active Comparator
Arm Title
DEX group (group D)
Arm Type
Active Comparator
Arm Title
heating combined with DEX group (group TD)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmetomidine
Intervention Description
Dexmetomidine (H20183219) 0.4μg / (kg·min)；
Intervention Type
Device
Intervention Name(s)
Lower limb heating blanket
Intervention Description
Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.
Primary Outcome Measure Information:
Title
Intraoperative vital signs monitoring
Description
nasopharyngeal temperature
Time Frame
1 hour
Title
Intraoperative vital signs monitoring
Description
nasopharyngeal temperature
Time Frame
2 hour
Title
Intraoperative vital signs monitoring
Description
nasopharyngeal temperature
Time Frame
3 hour
Title
The incidence of postoperative chills
Description
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.
Time Frame
1 hour
Title
The incidence of POD after operation
Description
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
Time Frame
1 day
Title
Postoperative extubation time
Description
The recovery time from the end of surgery to extubation was recorded.
Time Frame
1 hour
Title
Postoperative incision infection rate
Description
The incidence of postoperative incision infection was recorded.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jincheng General Hospital
City
Jincheng
State/Province
Shanxi
ZIP/Postal Code
048006
Country
China
12. IPD Sharing Statement
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Scheme of Limb Warming Blanket Combined With Dexmedetomidine
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