Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
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ClinicalTrials.gov Identifier: NCT02189655 |
Recruitment Status :
Withdrawn
First Posted : July 14, 2014
Last Update Posted : November 20, 2019
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Sponsor:
China Medical University, China
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China
Tracking Information | ||||
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First Submitted Date ICMJE | June 30, 2014 | |||
First Posted Date ICMJE | July 14, 2014 | |||
Last Update Posted Date | November 20, 2019 | |||
Study Start Date ICMJE | March 2016 | |||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
antishivering effects of two different types of spinal anesthesia [ Time Frame: time point 1: 15 minuntes after spinal anesthesia and time point 2 : when patiets were sent to postoperation care unit ] antishivering effects of two different types administration of spinal anesthesia
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects | |||
Official Title ICMJE | Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects | |||
Brief Summary | This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration. | |||
Detailed Description | This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.Group Control:traditional intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Antishivering Effects | |||
Intervention ICMJE | Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid
Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Estimated Study Completion Date ICMJE | December 2021 | |||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02189655 | |||
Other Study ID Numbers ICMJE | 20140630 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wen-fei Tan, China Medical University, China | |||
Study Sponsor ICMJE | China Medical University, China | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | China Medical University, China | |||
Verification Date | November 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |