Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography

Shivering Clinical Trial

— SHIVERS  

Official title:

Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography: A Randomised Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03566628
• Other study ID #: UV-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 2019

Study information

• Verified date: January 2019
• Source: Universidad de Valparaiso
• Contact: Nathalie Lopez, MD
• Phone: 2364000
• Email: nathalielopez.jq[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates whether the use of warmed solutions during cerebral angiography reduces the incidence of post-anaesthetic shivering. Half of participants will receive pre-warmed (39ºC) isotonic saline, while the other half receives the same solution at room temperature.

Description:

Shivering is a physiologic reaction aimed at raising body temperature that is very common amongst patients undergoing cerebral angiographies. The use of pre-warmed solutions during the procedure may reduce the incidence of shivering amongst these patients. In this triple-blind randomised trial, a consecutive sample of participants receiving total intravenous anaesthesia (TIVA) and undergoing cerebral angiography will be allocated to receive a warmed (39ºC) solution of up to 500cc of isotonic saline or the same solution, but at room temperature. Patients requiring sedation, those expected to require mechanical ventilation after the procedure, those with diminished consciousness (Glasgow Coma Scale <15 pts) and patients not wishing to participate will be excluded from the study. The primary endpoint for this study is the incidence of shivering up to 60 minutes after the procedure is completed. Shivering will be assessed using a validated scale by operators unaware of treament allocation. All analyses will be undertaken by a statistician that will not participate of the clinical assessment of included patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving TIVA

• Patients undergoing cerebral angiography

Exclusion Criteria:

• Glasgow Coma Scale <15 points prior to procedure

• Expected need of mechanical ventilation after procedure completion

• Use of sedatives

• Refusal to participate

Related Conditions & MeSH terms

• Cerebral Angiography
• Shivering

Intervention

Other:
• Warmed Isotonic Saline
Isotonic saline warmed to 39ºC.
• Room-Temperature Isotonic Saline
Isotonic saline at room temperature

Locations

Country	Name	City	State
Chile	Hospital Carlos Van Buren	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Hospital Carlos van Buren Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprocedural Shivering	Once the procedure is completed, the patient will be extubated and the presence or absence of shivering will be recorded up to 60 minutes after the extubation with the Badjatia 2008 scale consisting of a gradual evaluation of 0 to 3 points. With scores greater or equal to 1, shivering is considered established.	up to 60 minutes
Secondary	Shivering severity	The post operative shivering scale of Badjatia 2008 will be used. It consist of a gradual evaluation of 0 to 3 points, with 0 being the absence of shivering, 1 slight shivering, 2 moderate and 3 severe. The highest score obtained will be recorded within the measurements made every 5 minutes in the first 60 minutes after extubation.	60 minutes