Antishivering EffectsNCT02189655
Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
A study testing bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid in people with Antishivering Effects, run by China Medical University, China at 1 site in China.
Trial summary
This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antishivering Effects
- What is being tested?
- bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.
Read the 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
- Conditions
- Antishivering Effects
- Being tested
- bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid
- Keywords
- shivering spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluidProcedure or surgery
Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds. |
| Group Diluting with cerebrospinal fluid | Experimental | Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds Receives: Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
antishivering effects of two different types of spinal anesthesia
antishivering effects of two different types administration of spinal anesthesia
Measured: time point 1: 15 minuntes after spinal anesthesia and time point 2 : when patiets were sent to postoperation care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startMar 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antishivering EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, M.D.,Ph.D, Study director, The First Hospital of CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189655
- Sponsor's protocol ID
- 20140630
- Status last verified
- Nov 2019
- First submitted
- 30 Jun 2014
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
- ClinicalTrials.gov ID
- NCT02189655
- Acronym / sponsor ID
- 20140630
- Conditions
- Antishivering Effects
- Keywords
- shivering spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | –Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds. |
| Group Diluting with cerebrospinal fluid | Experimental | Procedure: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluidHyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluidHyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds | Procedure or surgery | Group Diluting with cerebrospinal fluid |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Ma, M.D.,Ph.D study director
The First Hospital of CMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid in people with Antishivering Effects, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.