UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042760 |
|---|---|
| Receipt number | R000048772 |
| Scientific Title | Comparison of intranasal and intravenous dexmedetomidine for prevention of post spinal shivering in patients undergoing lower limb orthopedic surgery |
| Date of disclosure of the study information | 2020/12/28 |
| Last modified on | 2023/06/17 12:04:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of intranasal and intravenous dexmedetomidine for prevention of post spinal shivering in patients undergoing lower limb orthopedic surgery
Acronym
dexmedetomidine and shivering
Scientific Title
Comparison of intranasal and intravenous dexmedetomidine for prevention of post spinal shivering in patients undergoing lower limb orthopedic surgery
Scientific Title:Acronym
dexmedetomidine and shivering
Region
| Asia(except Japan) |
Condition
Condition
Patients undergoing elective lower limb orthopedic surgeries under subarachnoid blockade were recruited into the study.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the prophylactic effectiveness of intranasal and intravenous dexmedetomidine for prevention of perioperative shivering.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were the incidence and intensity of shivering.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In group C, normal saline was administered intranasally 40 min before spinal anesthesia and intravenously 30 min following nasal medication, respectively.
Interventions/Control_2
In group V, normal saline was administered intranasally 40 min before spinal anesthesia and dexmedetomidine 1 microgram/kg was administered intravenously 30 min following nasal medication.
Interventions/Control_3
In group N, dexmedetomidine 1 microgram/kg was administered intranasally 40 min before spinal anesthesia and normal saline was administered intravenously 30 min following nasal medication.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients (ASA grades I to II) scheduled for elective lower limb orthopedic surgery under subarachnoid blockade were included in this study.
Key exclusion criteria
1, obese;
2, taking vasoactive or antidepressant drugs, receiving intraoperative blood or blood products transfusion;
3, with cardiac disease (heart blocks, bradyarrhythmias, and left ventricular failure), renal disease, hepatic disease, psychiatric disorder, neuropathies or severe diabetic autonomic neuropathy;
4, known history of substance or alcohol abus;
5, with a contraindication to regional anesthesia;
6, known allergy or hypersensitivity to dexmedetomidine and local anaesthetics;
7, history of nasal operation and nasal diseases, including rhinitis, nasal polyp, and nasosinusitis;
8, cardiovascular comorbidity, including bradycardia and atrioventricular block;
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
cjandsh@tmmu.edu.cn
Public contact
Name of contact person
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
Homepage URL
cjandsh@tmmu.edu.cn
Sponsor or person
Institute
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the People's Hospital of Chongqing Banan District
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing 401320, P.R China
Tel
+81-086-23-66291798
409560509@qq.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048772
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048772
Number of participants that the trial has enrolled
50
Results
N.A.
Results date posted
| 2023 | Year | 06 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences in the demographic characteristics and procedure details among the three groups.
Participant flow
Ultimately, a total of 50 elderly patients (43 males) were evaluated.
Adverse events
There were significant bradycardic in the two dexmedetomidine groups.
Outcome measures
N.A.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048772
