Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension
NCT ID: NCT02845921
Last Updated: 2016-07-27
Study Results
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group C Control
Patient will be shifted to operation theatre. Electrocardiography (ECG), pulse oximeter and non-invasive blood pressure (NIBP) monitors will be attached. Baseline vitals will be noted. Intravenous access will be secured and crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be neither elevated or wrapped. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube.
control
no intervention has been done
Group E Leg elevation
Patient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs are elevated and supported on a stand making an angle of 30 degree to the horizontal. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Stand will be removed and legs will be brought to horizontal position 10 minutes after intubation.
leg elevation
A stand making an angle of 30 degree to the horizontal is used to elevate both the legs
Group W Leg wrapping
Patient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl. Each lower limb will be elevated alternately and wrapped from toe to mid-thigh with Esmarch bandage. Care will be taken to avoid compressing the legs to greater than arterial pressure by confirming the presence of pulse using a saturation probe. Following wrapping, the lower limbs will be brought to horizontal position. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol injected over 30 seconds. Muscle relaxation by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Esmarch bandage will be removed 10 minutes after intubation.
leg wrapping
Esmarch bandage is used to wrap each lower limb
Interventions
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leg elevation
A stand making an angle of 30 degree to the horizontal is used to elevate both the legs
leg wrapping
Esmarch bandage is used to wrap each lower limb
control
no intervention has been done
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Nitte University
OTHER
Responsible Party
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Dr. Sara Jaison
Junior Resident
Principal Investigators
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Sripada G Mehandale, MBBS, MD
Role: STUDY_DIRECTOR
Associate Professor
Locations
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Justice K. S. Hegde Hospital, K S Hegde Medical Academy, Nitte University
Mangalore, Dakshina Kannada, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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
Other Identifiers
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INST.EC/EC/066/2015-16
Identifier Type: -
Identifier Source: org_study_id
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