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TremorPhase 3NCT02384343

Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia

A Phase 3 study testing Dexmedetomidine and Normal saline in people with Tremor, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Tremor
What is being tested?
Dexmedetomidine and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteCanada
Study dates
Apr 2015to Jun 2016
Phase
Phase 3
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cesarean delivery under neuraxial anesthesia (epidural or spinal) planned or unplanned between 8 am and 8 pm on week days when one of the investigator is present.
  • Participants with fever or shivering before the cesarean section are include

Who cannot join

  • No comprehension of french or english language
  • Urgent cesarean delivery for non reassuring fetal tracing
  • Extremely urgent cesarean delivery (grade 1)
  • Weight < 60 kg ou > 120 kg
  • Hypersensibility to dexmedetomidine
  • Heart, renal or hepatic disease requiring follow up, medication or with a possibility of instability during cesarean delivery
Show all 10Show fewer
  • Pre-eclampsia
  • Combined spinal-epidural anesthesia
  • Conversion into general anesthesia
  • Blood products transfusions or major complications during surgery

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St-Justine's Hospital

    Montreal, Quebec, H3T 1C4

Other trials in Canada

About this study

Official title: Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia: A Randomized Controlled Trial

The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery.

Conditions
Tremor
Being tested
Dexmedetomidine, Normal saline
Keywords
Dexmedetomidine, Cesarean section, Anesthesia, Spinal, Anesthesia, Epidural
Medical subject headings
Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex

    An intravenous bolus of dexmedetomidine 30 mcg (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan.

  • Normal salineDrug

    Also called NaCl 0,9%

    An intravenous bolus of normal saline (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan.

Study groups in NCT02384343
Study groupRoleWhat they receive
DexmedetomidineActive comparatorDexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus
Receives: Drug: Dexmedetomidine
Normal salinePlacebo comparatorNaCl 0,9% 7,5 ml, single intravenous bolus
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for cessation of shivering after bolus (min)

    Graded on a four point scale as per Crossley and Mahajan

    Measured: Within the first 15 minutes of administration of bolus

Secondary outcomes (3)

  1. Incidence of bradycardia

    Heart rate below 50 bpm

    Measured: From the administration of bolus to the end of surgery, an expected average of 1 hour

  2. Incidence of hypotension

    A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure

    Measured: From the administration of bolus to the end of surgery, an expected average of 1 hour

  3. Incidence of sedation

    Graded on a four point scale as per Filos et al

    Measured: From the administration of bolus to the end of surgery, an expected average of 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2016
  4. Study completionJun 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02384343
Sponsor's protocol ID
050115
Status last verified
Apr 2018
First submitted
4 Mar 2015
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031.

    PubMed 25024466

  • Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006.

    PubMed 18433676

  • Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. doi: 10.1111/j.1365-2044.1994.tb03422.x.

    PubMed 8147511

  • Lamontagne C, Lesage S, Villeneuve E, Lidzborski E, Derstenfeld A, Crochetiere C. Intravenous dexmedetomidine for the treatment of shivering during Cesarean delivery under neuraxial anesthesia: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):762-771. doi: 10.1007/s12630-019-01354-3. Epub 2019 Apr 3.

    PubMed 30945105

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine and Normal saline in people with Tremor, run by St. Justine's Hospital at 1 site in Canada.

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 2 inclusion and 10 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: finished, as of the sponsor's last update on 19 Apr 2018. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time for cessation of shivering after bolus (min) (time frame: Within the first 15 minutes of administration of bolus). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384343, which also lists 4 linked publications.

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 19 Apr 2018.

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