Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects

• ClinicalTrials.gov Identifier: NCT02189655
• Recruitment Status: Withdrawn
• First Posted: July 14, 2014
• Last Update Posted: November 20, 2019
• Sponsor: China Medical University, China
• Information provided by (Responsible Party): Wen-fei Tan, China Medical University, China

Tracking Information

• First Submitted Date: June 30, 2014
• First Posted Date: July 14, 2014
• Last Update Posted Date: November 20, 2019
• Study Start Date: March 2016
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Antishivering Effects

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: November 18, 2019): 0
• Original Estimated Enrollment (submitted: July 10, 2014): 100
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02189655
• Other Study ID Numbers: 20140630
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wen-fei Tan, China Medical University, China
• Study Sponsor: China Medical University, China
• Collaborators: Not Provided

Investigators

• Study Director: Hong Ma, M.D.,Ph.D; The First Hospital of CMU

• PRS Account: China Medical University, China
• Verification Date: November 2019