Spine SurgeryNCT05857410
Scheme of Limb Warming Blanket Combined With Dexmedetomidine
A study testing Dexmetomidine and Lower limb heating blanket in people with Spine Surgery and Postoperative Delirium and Chills, run by Jincheng General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Spine Surgery, Postoperative Delirium and Chills
- What is being tested?
- Dexmetomidine and Lower limb heating blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spine Surgery, Postoperative Delirium and Chills
- Being tested
- Dexmetomidine, Lower limb heating blanket
- Keywords
- Elderly spinal surgery, Delirium and chills
- Medical subject headings
- Emergence Delirium, Chills, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmetomidineDrug
Dexmetomidine (H20183219) 0.4μg / (kg·min)；
Lower limb heating blanketDevice
Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.
| Study group | Role | What they receive |
|---|---|---|
| control group (group N) | No intervention | Not described |
| heating group (group T) | Active comparator | Not described Receives: Device: Lower limb heating blanket |
| DEX group (group D) | Active comparator | Not described Receives: Drug: Dexmetomidine |
| heating combined with DEX group (group TD) | Experimental | Not described Receives: Drug: Dexmetomidine; Device: Lower limb heating blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative vital signs monitoring
nasopharyngeal temperature
Measured: 1 hour
Intraoperative vital signs monitoring
nasopharyngeal temperature
Measured: 2 hour
Intraoperative vital signs monitoring
nasopharyngeal temperature
Measured: 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.
Measured: 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
Measured: 1 day
Postoperative extubation time
The recovery time from the end of surgery to extubation was recorded.
Measured: 1 hour
Postoperative incision infection rate
The incidence of postoperative incision infection was recorded.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jan 2019
- Primary completion30 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jincheng General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Fan, Jincheng General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857410
- Sponsor's protocol ID
- JinchengGH001
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05857410
- Acronym / sponsor ID
- JinchengGH001
- Conditions
- Spine Surgery, Postoperative Delirium and Chills
- Keywords
- Elderly spinal surgery, Delirium and chills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Jincheng General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group (group N) | No intervention | – |
| heating group (group T) | Active comparator | Device: Lower limb heating blanket |
| DEX group (group D) | Active comparator | Drug: Dexmetomidine |
| heating combined with DEX group (group TD) | Experimental | Drug: Dexmetomidine, Device: Lower limb heating blanket |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmetomidineDexmetomidine (H20183219) 0.4μg / (kg·min)； | Drug | DEX group (group D), heating combined with DEX group (group TD) |
| Lower limb heating blanketBeijing Maikang Medical Device Co., Ltd., Model: Warm-1-1. | Device | heating combined with DEX group (group TD), heating group (group T) |
Primary outcome
Intraoperative vital signs monitoring
Time frame: 1 hour
nasopharyngeal temperature
Intraoperative vital signs monitoring
Time frame: 2 hour
nasopharyngeal temperature
Intraoperative vital signs monitoring
Time frame: 3 hour
nasopharyngeal temperature
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.
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
Postoperative extubation time
Time frame: 1 hour
The recovery time from the end of surgery to extubation was recorded.
Postoperative incision infection rate
Time frame: 1 hour
The incidence of postoperative incision infection was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmetomidine and Lower limb heating blanket in people with Spine Surgery and Postoperative Delirium and Chills, run by Jincheng General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative vital signs monitoring (time frame: 1 hour). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.