Propofol Induced Hypotension Clinical Trial
Official title:
Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension: A Prospective Randomised Controlled Study
Propofol is an intravenous anaesthetic agent used for both induction and maintenance of anaesthesia. An important adverse effect is the significant fall in blood pressure. The current clinical study will be done to determine the efficacy of leg elevation and wrapping in reducing the incidence and severity of propofol induced hypotension in patients undergoing general anaesthesia.
Propofol is an intravenous anaesthetic agent used for both induction and maintenance of
anaesthesia. It is widely employed due to its quick onset of action, short half life and
rapid recovery. An important adverse effect is the significant fall in blood pressure.
Although the exact mechanism of propofol induced hypotension is not known, venodilation,
decreased peripheral resistance and decrease in cardiac output has been suggested.2 Though
the hypotension is transient, it can produce devastating effects. Hence there is a need to
prevent it. Moreover, several attempts at treating propofol induced hypotension have been
met with variable and limited success.
Hypotension following spinal anaesthesia is also a frequent problem. It is generally treated
with intravenous fluids and vasopressors. Simple and non pharmacological measures like leg
elevation and leg wrapping with Esmarch bandage were reported to be successful.3 These
reduce the incidence and severity of hypotension associated with spinal anaesthesia by
improving the venous return.
The mechanisms of hypotension following intravenous propofol and spinal anaesthesia are
almost similar. Therefore, the investigators hypothesize that leg elevation and wrapping can
be attempted to reduce propofol induced hypotension. They are simple and cost effective
techniques that will reduce the need for pharmacological measures to control hypotension. As
the literature search did not reveal any information regarding the usefulness of these
techniques in propofol induced hypotension, the current clinical study will be done to
determine the efficacy of leg elevation and wrapping in reducing the incidence and severity
of propofol induced hypotension in patients undergoing general anaesthesia.
The current study will compare the efficacy of leg elevation and leg wrapping in reducing
the incidence and severity of propofol induced hypotension in terms of incidence of
hypotension, magnitude of decrease in systolic, diastolic and mean arterial blood pressures,
need for pharmacological measures to treat hypotension, changes in heart rate and adverse
clinical outcomes, if any. It will be a prospective randomised controlled open label study
from January 2016 to August 2017 involving 150 adult patients undergoing general
anaesthesia.
For statistical analysis, descriptive statistics - minimum, maximum, mean and standard
deviation will be used. Independent sample t test for data following normal distribution and
for data not following normal distribution, Mann-Whitney U test will be used. P value less
than 0.05 will be considered statistically significant. To study relationship between
hypotension and other variables, Pearson's correlation will be used. Confidence interval
will be calculated to 95%.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention