Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-11-30

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.

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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.

Conditions

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Cerebral Angiography Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Warmed 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.

Group Type EXPERIMENTAL

Warmed Isotonic Saline

Intervention Type OTHER

Isotonic saline warmed to 39ºC.

Room-Temperature 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.

Group Type ACTIVE_COMPARATOR

Room-Temperature Isotonic Saline

Intervention Type OTHER

Isotonic saline at room temperature

Interventions

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Warmed Isotonic Saline

Isotonic saline warmed to 39ºC.

Intervention Type OTHER

Room-Temperature Isotonic Saline

Isotonic saline at room temperature

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No