Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Angiography, Shivering

Intervention / Treatment
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* Other: Warmed Isotonic Saline
* Other: Room-Temperature Isotonic Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warmed Saline<br>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. | Other: Warmed Isotonic Saline<br>* Isotonic saline warmed to 39ºC.<br>|
| Active Comparator: Room-Temperature Saline<br>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. | Other: Room-Temperature Isotonic Saline<br>* Isotonic saline at room temperature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Angiography, Shivering, Anaesthesia, Warmed solutions