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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042760
Receipt No. 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 2020/12/15

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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
Email 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
Email cjandsh@tmmu.edu.cn

Sponsor
Institute Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2020 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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