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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Recruitment Status : Withdrawn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

Tracking Information
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
 (submitted: July 10, 2014)
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
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
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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 18, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Hong Ma, M.D.,Ph.D The First Hospital of CMU
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