Trial record 5 of 22 for:    mahajan

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2015 by St. Justine's Hospital
Sponsor:
Information provided by (Responsible Party):
Christina Lamontagne, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT02384343
First received: March 4, 2015
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Tremor
Drug: Dexmedetomidine
Drug: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Time for cessation of shivering after bolus (min) [ Time Frame: Within the first 15 minutes of administration of bolus ] [ Designated as safety issue: No ]
    Graded on a four point scale as per Crossley and Mahajan


Secondary Outcome Measures:
  • Incidence of bradycardia [ Time Frame: From the administration of bolus to the end of surgery, an expected average of 1 hour ] [ Designated as safety issue: Yes ]
    Heart rate below 50 bpm

  • Incidence of hypotension [ Time Frame: From the administration of bolus to the end of surgery, an expected average of 1 hour ] [ Designated as safety issue: Yes ]
    A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure

  • Incidence of sedation [ Time Frame: From the administration of bolus to the end of surgery, an expected average of 1 hour ] [ Designated as safety issue: No ]
    Graded on a four point scale as per Filos et al


Estimated Enrollment: 80
Study Start Date: April 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine
Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus
Drug: Dexmedetomidine
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.
Other Name: Precedex
Placebo Comparator: Normal saline
NaCl 0,9% 7,5 ml, single intravenous bolus
Drug: Normal saline
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.
Other Name: NaCl 0,9%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pre-eclampsia
  • Combined spinal-epidural anesthesia
  • Conversion into general anesthesia
  • Blood products transfusions or major complications during surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02384343

Contacts
Contact: Chantal Crochetière, MD, FRCP 514 345-4788 chantal_crochetiere@ssss.gouv.qc.ca
Contact: Sophie Perreault, inf, CCRP 514 345-4931 ext 2937 sophie.perreault@recherche-ste-justine.qc.ca

Locations
Canada, Quebec
St-Justine's Hospital Not yet recruiting
Montréal, Quebec, Canada, H3T 1C4
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Christina Lamontagne, MD St. Justine's Hospital
Study Director: Chantal Crochetière, MD, FRCP St. Justine's Hospital
Study Chair: Edith Villeneuve St. Justine's Hospital
Study Chair: Sandra Lesage St. Justine's Hospital
  More Information

Publications:
Responsible Party: Christina Lamontagne, MD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02384343     History of Changes
Other Study ID Numbers: 050115
Study First Received: March 4, 2015
Last Updated: April 23, 2015
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Dexmedetomidine
Cesarean section
Anesthesia, Spinal
Anesthesia, Epidural

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015