Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography

Not Applicable

• Conditions: Cerebral Angiography; Shivering
• Interventions: Other: Warmed Isotonic Saline; Other: Room-Temperature Isotonic Saline

• Registration Number: NCT03566628
• Lead Sponsor: Universidad de Valparaiso

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30
• Study Start: 2019-02-01
• Primary Completion: 2019-09
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warmed Saline	Warmed Isotonic Saline	Patients allocated to this arm will receive a warmed (39ºC) solution of up to 500mL of isotonic saline. This solution will be administered directly to the cerebral vasculature as part of the angiography.
Room-Temperature Saline	Room-Temperature Isotonic Saline	Patients allocated to this arm will receive isotonic saline at room temperature. This solution will be administered directly to the cerebral vasculature as part of the angiography.

Primary Outcome Measures

Name	Time	Method
Postprocedural Shivering	up to 60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Shivering severity	60 minutes	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.

Trial Locations

Locations (1)

Hospital Carlos Van Buren; 🇨🇱 Valparaiso, Chile