Scheme of Limb Warming Blanket Combined With Dexmedetomidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-01-25

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.

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Detailed Description

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Conditions

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Spine Surgery Postoperative Delirium and Chills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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control group (group N)

Group Type NO_INTERVENTION

No interventions assigned to this group

heating group (group T)

Group Type ACTIVE_COMPARATOR

Lower limb heating blanket

Intervention Type DEVICE

Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.

DEX group (group D)

Group Type ACTIVE_COMPARATOR

Dexmetomidine

Intervention Type DRUG

Dexmetomidine (H20183219) 0.4μg / (kg·min)；

heating combined with DEX group (group TD)

Group Type EXPERIMENTAL

Dexmetomidine

Intervention Type DRUG

Dexmetomidine (H20183219) 0.4μg / (kg·min)；

Lower limb heating blanket

Intervention Type DEVICE

Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.

Interventions

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Dexmetomidine

Dexmetomidine (H20183219) 0.4μg / (kg·min)；

Intervention Type DRUG

Lower limb heating blanket

Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.

Intervention Type DEVICE

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No