Cerebral Angiography, Shivering
Conditions
Keywords
Cerebral Angiography, Shivering, Anaesthesia, Warmed solutions
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.
Interventions
OTHERWarmed Isotonic Saline
Isotonic saline warmed to 39ºC.
OTHERRoom-Temperature Isotonic Saline
Isotonic saline at room temperature
Sponsors
Hospital Carlos Van Buren
Universidad de Valparaiso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Chile
Contacts
Primary ContactNathalie Lopez, MD
Backup ContactFelipe Martinez, M.D; M.Sc.
Outcome results
None listed