Clinical trial NCT02845921: Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension
Official title: Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension: A Prospective Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Propofol Induced Hypotension
Keywords: Propofol
Hypotension
Induction of anaesthesia
Leg elevation
Leg wrapping
Lead sponsor: Nitte University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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%.

Eligibility criteria: Inclusion Criteria:

* Patients belonging to ASA physical status I and II undergoing endotracheal general anaesthesia

Exclusion Criteria:

* Patient refusal
* Contraindication to application of bandage
* Partial or complete limb amputation
* Difficult airway
* Use of extraglottic airway device
* Pregnancy
* On antihypertensive or vasoactive medication
* Autonomic neuropathy

Primary outcomes:
measure: incidence of hypotension at baseline
timeFrame: baseline
measure: incidence of hypotension at 0 minutes after leg elevation or wrapping
timeFrame: 0 minutes after leg elevation or wrapping
measure: incidence of hypotension at 0 minutes after induction with propofol
timeFrame: 0 minutes after induction with propofol
measure: incidence of hypotension at 1 minute after induction
timeFrame: 1 minute after induction
measure: incidence of hypotension at 2 minutes after induction
timeFrame: 2 minutes after induction
measure: incidence of hypotension at 3 minutes after induction
timeFrame: 3 minutes after induction
measure: incidence of hypotension at 4 minutes after induction
timeFrame: 4 minutes after induction
measure: incidence of hypotension at 5 minutes after induction
timeFrame: 5 minutes after induction
measure: incidence of hypotension at 0 minutes after intubation
timeFrame: 0 minutes after intubation
measure: incidence of hypotension at 1 minute after intubation
timeFrame: 1 minute after intubation
measure: incidence of hypotension at 2 minutes after intubation
timeFrame: 2 minutes after intubation
measure: incidence of hypotension at 3 minutes after intubation
timeFrame: 3 minutes after intubation
measure: incidence of hypotension at 4 minutes after intubation
timeFrame: 4 minutes after intubation
measure: incidence of hypotension at 5 minutes after intubation
timeFrame: 5 minutes after intubation
measure: incidence of hypotension at 6 minutes after intubation
timeFrame: 6 minutes after intubation
measure: incidence of hypotension at 7 minutes after intubation
timeFrame: 7 minutes after intubation
measure: incidence of hypotension at 8 minutes after intubation
timeFrame: 8 minutes after intubation
measure: incidence of hypotension at 9 minutes after intubation
timeFrame: 9 minutes after intubation
measure: incidence of hypotension at 10 minutes after intubation
timeFrame: 10 minutes after intubation
Secondary outcomes:
measure: Magnitude of change in systolic blood pressure from baseline at 0 minutes after leg leg elevation or wrapping
timeFrame: baseline, after leg elevation or wrapping
measure: Magnitude of change in systolic blood pressure from baseline at 0 minutes after induction
timeFrame: baseline, at 0 minutes after induction with propofol
measure: Magnitude of change in systolic blood pressure from baseline at 1 minute after induction
timeFrame: baseline, at 1 minute after induction with propofol
measure: Magnitude of change in systolic blood pressure from baseline at 2 minutes after induction
timeFrame: baseline, at 2 minutes after induction with propofol
measure: Magnitude of change in systolic blood pressure from baseline at 3 minutes after induction
timeFrame: baseline, at 3 minutes after induction with propofol
measure: Magnitude of change in systolic blood pressure from baseline at 4 minutes after induction
timeFrame: baseline, at 4 minutes after induction with propofol
measure: Magnitude of change in systolic blood pressure from baseline at 5 minutes after induction
timeFrame: baseline, at 5 minutes after induction with propofol
measure: Magnitude of change in systolic blood pressure from baseline at 0 minutes after intubation
timeFrame: baseline, at 0 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 1 minute after intubation
timeFrame: baseline, at 1 minute after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 2 minutes after intubation
timeFrame: baseline, at 2 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 3 minutes after intubation
timeFrame: baseline, at 3 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 4 minutes after intubation
timeFrame: baseline, at 4 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 5 minutes after intubation
timeFrame: baseline, at 5 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 6 minutes after intubation
timeFrame: baseline, at 6 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 7 minutes after intubation
timeFrame: baseline, at 7 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 8 minutes after intubation
timeFrame: baseline, at 8 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 9 minutes after intubation
timeFrame: baseline, at 9 minutes after intubation
measure: Magnitude of change in systolic blood pressure from baseline at 10 minutes after intubation
timeFrame: baseline, at 10 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 0 minutes after leg elevation or wrapping
timeFrame: baseline, at 0 minutes after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 0 minutes after induction with propofol
timeFrame: baseline, at 0 minutes after induction with propofol
measure: Magnitude of change in diastolic blood pressure from baseline at 1 minute after induction with propofol
timeFrame: baseline, at 1 minute after induction with propofol
measure: Magnitude of change in diastolic blood pressure from baseline at 2 minutes after induction with propofol
timeFrame: baseline, at 2 minutes after induction with propofol
measure: Magnitude of change in diastolic blood pressure from baseline at 3 minutes after induction with propofol
timeFrame: baseline, at 3 minutes after induction with propofol
measure: Magnitude of change in diastolic blood pressure from baseline at 4 minutes after induction with propofol
timeFrame: baseline, at 4 minutes after induction with propofol
measure: Magnitude of change in diastolic blood pressure from baseline at 5 minutes after induction with propofol
timeFrame: baseline, at 5 minutes after induction with propofol
measure: Magnitude of change in diastolic blood pressure from baseline at 0 minutes after intubation
timeFrame: baseline, at 0 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 1 minute after intubation
timeFrame: baseline, at 1 minute after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 2 minutes after intubation
timeFrame: baseline, at 2 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 3 minutes after intubation
timeFrame: baseline, at 3 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 4 minutes after intubation
timeFrame: baseline, at 4 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 5 minutes after intubation
timeFrame: baseline, at 5 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 6 minutes after intubation
timeFrame: baseline, at 6 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 7 minutes after intubation
timeFrame: baseline, at 7 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 8 minutes after intubation
timeFrame: baseline, at 8 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 9 minutes after intubation
timeFrame: baseline, at 9 minutes after intubation
measure: Magnitude of change in diastolic blood pressure from baseline at 10 minutes after intubation
timeFrame: baseline, at 10 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 0 minutes after leg elevation or wrapping
timeFrame: baseline, 0 minutes after leg elevation or wrapping
measure: Magnitude of change in mean arterial blood pressure from baseline at 1 minute after induction with propofol
timeFrame: baseline, 0 minute after induction with propofol
measure: Magnitude of change in mean arterial blood pressure from baseline at 2 minutes after induction with propofol
timeFrame: baseline, 2 minutes after induction with propofol
measure: Magnitude of change in mean arterial blood pressure from baseline at 3 minutes after induction with propofol
timeFrame: baseline, 3 minutes after induction with propofol
measure: Magnitude of change in mean arterial blood pressure from baseline at 4 minutes after induction with propofol
timeFrame: baseline, 4 minutes after induction with propofol
measure: Magnitude of change in mean arterial blood pressure from baseline at 5 minutes after induction with propofol
timeFrame: baseline, 5 minutes after induction with propofol
measure: Magnitude of change in mean arterial blood pressure from baseline at 0 minute after intubation
timeFrame: baseline, 0 minute after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 1 minutes after intubation
timeFrame: baseline, 1 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 2 minutes after intubation
timeFrame: baseline, 2 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 3 minutes after intubation
timeFrame: baseline, 3 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 4 minutes after intubation
timeFrame: baseline, 4 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 5 minutes after intubation
timeFrame: baseline, 5 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 6 minutes after intubation
timeFrame: baseline, 6 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 7 minutes after intubation
timeFrame: baseline, 7 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 8 minutes after intubation
timeFrame: baseline, 8 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 9 minutes after intubation
timeFrame: baseline, 9 minutes after intubation
measure: Magnitude of change in mean arterial blood pressure from baseline at 10 minutes after intubation
timeFrame: baseline, 10 minutes after intubation
measure: changes in heart rate from baseline at 0 minutes after leg elevation or wrapping
timeFrame: baseline, 0 minutes after leg elevation or wrapping
measure: changes in heart rate from baseline at 0 minutes after induction with propofol
timeFrame: baseline, 0 minute after induction with propofol
measure: changes in heart rate from baseline at 1 minutes after induction with propofol
timeFrame: baseline, 1 minutes after induction with propofol
measure: changes in heart rate from baseline at 2 minutes after induction with propofol
timeFrame: baseline, 2 minutes after induction with propofol
measure: changes in heart rate from baseline at 3 minutes after induction with propofol
timeFrame: baseline, 3 minutes after induction with propofol
measure: changes in heart rate from baseline at 4 minutes after induction with propofol
timeFrame: baseline, 4 minutes after induction with propofol
measure: changes in heart rate from baseline at 5 minutes after induction with propofol
timeFrame: baseline, 5 minutes after induction with propofol
measure: changes in heart rate from baseline at 0 minutes after intubation
timeFrame: baseline, 0 minutes after intubation
measure: changes in heart rate from baseline at 1 minute after intubation
timeFrame: baseline, 1 minute after intubation
measure: changes in heart rate from baseline at 2 minutes after intubation
timeFrame: baseline, 2 minutes after intubation
measure: changes in heart rate from baseline at 3 minutes after intubation
timeFrame: baseline, 3 minutes after intubation
measure: changes in heart rate from baseline at 4 minutes after intubation
timeFrame: baseline, 4 minutes after intubation
measure: changes in heart rate from baseline at 5 minutes after intubation
timeFrame: baseline, 5 minutes after intubation
measure: changes in heart rate from baseline at 6 minutes after intubation
timeFrame: baseline, 6 minutes after intubation
measure: changes in heart rate from baseline at 7 minutes after intubation
timeFrame: baseline, 7 minutes after intubation
measure: changes in heart rate from baseline at 8 minutes after intubation
timeFrame: baseline, 8 minutes after intubation
measure: changes in heart rate from baseline at 9 minutes after intubation
timeFrame: baseline, 9 minutes after intubation
measure: changes in heart rate from baseline at 10 minutes after intubation
timeFrame: baseline, 10 minutes after intubation
Other outcomes:
measure: Need for pharmacological measures to treat hypotension
timeFrame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
measure: Tachycardia
timeFrame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
measure: Bradycardia
timeFrame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
measure: Arrhythmia
timeFrame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
Locations:
city: Mangalore
country: India
facility: Justice K. S. Hegde Hospital, K S Hegde Medical Academy, Nitte University
state: Dakshina Kannada
Study officials:
affiliation: Associate Professor
name: Sripada G Mehandale, MBBS, MD
role: STUDY_DIRECTOR
References:
citation: McNeir DA, Mainous EG, Trieger N. Propofol as an intravenous agent in general anesthesia and conscious sedation. Anesth Prog. 1988 Jul-Aug;35(4):147-51.
citation: Muzi M, Berens RA, Kampine JP, Ebert TJ. Venodilation contributes to propofol-mediated hypotension in humans. Anesth Analg. 1992 Jun;74(6):877-83. doi: 10.1213/00000539-199206000-00017.
citation: Rout CC, Rocke DA, Gouws E. Leg elevation and wrapping in the prevention of hypotension following spinal anaesthesia for elective caesarean section. Anaesthesia. 1993 Apr;48(4):304-8. doi: 10.1111/j.1365-2044.1993.tb06948.x.
citation: Masoudifar M, Beheshtian E. Comparison of cardiovascular response to laryngoscopy and tracheal intubation after induction of anesthesia by Propofol and Etomidate. J Res Med Sci. 2013 Oct;18(10):870-4.
citation: Moller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate: a double-blind, randomized, clinical trial. Br J Anaesth. 2013 Mar;110(3):388-96. doi: 10.1093/bja/aes416. Epub 2012 Nov 19.
citation: Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
citation: Singh K, Payal YS, Sharma JP, Nautiyal R. Evaluation of hemodynamic changes after leg wrapping in elective cesarean section under spinal anesthesia. J Obstet Anaesth Crit Care. 2014;4:23-8