Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
Sponsor
China Medical University, China (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02189655
Collaborator
(none)
0
1
2
69
0
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
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
:
Mar 1, 2016
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Dec 1, 2021
Arms and Interventions
| 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
Primary Outcome Measures
- antishivering effects of two different types of spinal anesthesia [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
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Hospital of China Medical University | Shenyang | Liaoning | China | 110001 |
Sponsors and Collaborators
- China Medical University, China
Investigators
- Study Director: Hong Ma, M.D.,Ph.D, The First Hospital of CMU
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.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:
Jul 14, 2014
Last Update Posted:
Nov 20, 2019
Last Verified:
Nov 1, 2019
Keywords provided by Wen-fei Tan,
Department of Anesthesiology, The First Hospital of CMU,
China Medical University, China
Additional relevant MeSH terms: