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

Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384343
• Other study ID #: 050115
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2015
• Last updated: April 17, 2018
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2018
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tremor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St-Justine's Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for cessation of shivering after bolus (min)	Graded on a four point scale as per Crossley and Mahajan	Within the first 15 minutes of administration of bolus
Secondary	Incidence of bradycardia	Heart rate below 50 bpm	From the administration of bolus to the end of surgery, an expected average of 1 hour
Secondary	Incidence of hypotension	A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure	From the administration of bolus to the end of surgery, an expected average of 1 hour
Secondary	Incidence of sedation	Graded on a four point scale as per Filos et al	From the administration of bolus to the end of surgery, an expected average of 1 hour