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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Recruitment Status : Withdrawn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
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

Study Description
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Brief Summary:
This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.

Condition or disease Intervention/treatment Phase
Antishivering Effects Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
Study Start Date : March 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Group Control
Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds.
Experimental: Group Diluting with cerebrospinal fluid
Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled.

Exclusion Criteria:

  • Patients with pre-operative fever (>38℃), diabetes, , Parkinson's disease, hypo or hyperthyroidism, Raynaud's syndrome, obese patients (weight >100 kg), patients shorter than 152 cm, those with a history of allergy to the study medications, and patients receiving vasodilators were excluded from the study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189655


Locations
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China, Liaoning
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
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Study Director: Hong Ma, M.D.,Ph.D The First Hospital of CMU
More Information
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Responsible Party: Wen-fei Tan, Department of Anesthesiology, The First Hospital of CMU, China Medical University, China
ClinicalTrials.gov Identifier: NCT02189655    
Other Study ID Numbers: 20140630
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Keywords provided by Wen-fei Tan, China Medical University, China:
shivering spinal anesthesia
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents