Back to resultsIntravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia
Primary Purpose
Tremor
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Tremor focused on measuring Dexmedetomidine, Cesarean section, Anesthesia, Spinal, Anesthesia, Epidural
Eligibility 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
Sites / Locations
- St-Justine's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexmedetomidine
Normal saline
Arm Description
Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus
NaCl 0,9% 7,5 ml, single intravenous bolus
Outcomes
Primary Outcome Measures
Time for cessation of shivering after bolus (min)
Graded on a four point scale as per Crossley and Mahajan
Secondary Outcome Measures
Incidence of bradycardia
Heart rate below 50 bpm
Incidence of hypotension
A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure
Incidence of sedation
Graded on a four point scale as per Filos et al
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02384343
Brief Title
Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia
Official Title
Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tremor
Keywords
Dexmedetomidine, Cesarean section, Anesthesia, Spinal, Anesthesia, Epidural
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
NaCl 0,9% 7,5 ml, single intravenous bolus
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NaCl 0,9%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time for cessation of shivering after bolus (min)
Description
Graded on a four point scale as per Crossley and Mahajan
Time Frame
Within the first 15 minutes of administration of bolus
Secondary Outcome Measure Information:
Title
Incidence of bradycardia
Description
Heart rate below 50 bpm
Time Frame
From the administration of bolus to the end of surgery, an expected average of 1 hour
Title
Incidence of hypotension
Description
A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure
Time Frame
From the administration of bolus to the end of surgery, an expected average of 1 hour
Title
Incidence of sedation
Description
Graded on a four point scale as per Filos et al
Time Frame
From the administration of bolus to the end of surgery, an expected average of 1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Lamontagne, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chantal Crochetière, MD, FRCP
Organizational Affiliation
St. Justine's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Edith Villeneuve
Organizational Affiliation
St. Justine's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandra Lesage
Organizational Affiliation
St. Justine's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St-Justine's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25024466
Citation
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.
Results Reference
background
PubMed Identifier
18433676
Citation
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.
Results Reference
background
PubMed Identifier
8147511
Citation
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.
Results Reference
background
PubMed Identifier
30945105
Citation
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.
Results Reference
derived
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Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia
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