Skip to main content
OpenTrials
Completed

NCT Number: NCT05857410

Scheme of Limb Warming Blanket Combined With Dexmedetomidine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spine Surgery Chills Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium and Chills Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jincheng General Hospital

Jincheng, Shanxi, 048006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmetomidine

Drug

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

Lower limb heating blanket

Device

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

Primary outcomes

  1. Intraoperative vital signs monitoring

    Time frame: 1 hour

    nasopharyngeal temperature

  2. Intraoperative vital signs monitoring

    Time frame: 2 hour

    nasopharyngeal temperature

  3. Intraoperative vital signs monitoring

    Time frame: 3 hour

    nasopharyngeal temperature

  4. The incidence of postoperative chills

    Time frame: 1 hour

    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.

  5. The incidence of POD after operation

    Time frame: 1 day

    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

  6. Postoperative extubation time

    Time frame: 1 hour

    The recovery time from the end of surgery to extubation was recorded.

  7. Postoperative incision infection rate

    Time frame: 1 hour

    The incidence of postoperative incision infection was recorded.

Sponsors and collaborators

Lead sponsor

Jincheng General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
May 12, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.