Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol

Overview

Although propofol is widely used as an induction agent for a general anesthesia, it can induce a profound hypotension, which leads to the hypo-perfusion of end organs and eventually increases morbidities. Theoretically, applying Trendelenburg position (head down and leg up position) increases cardiac preloads and cardiac outputs. However, in past researches, changing to Trendelenburg position alone is not enough and does not prevent propofol induced hypotension. Previous studies proved that leg wrapping effectively prevent hypotension after neuraxial anesthesia during Cesarean section. The leg wrapping prevents hypotension by increasing vascular resistance of lower extremities. The investigators made a hypothesis that applying both Trendelenburg position and leg wrapping prevent propofol induced hypotension more effectively than either applying Trendelenburg position only or taking no preventive measures.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2018

Detailed Description

** Study procedure

1. check baseline blood pressure ( systolic, diastolic, mean) and heart rate.

2. apply pre-defined measures to each group(arm) ( summarized in arms and interventions section )

3. induction using propofol 2mg/kg

4. After bispectral index (BIS) goes below 60 & patient become unconsciousness, inject rocuronium 0.6mg/kg

5. intubate patient between 3 and 4 minutes after propofol injection

6. measure blood pressure ( systolic, diastolic, mean ) & heart rate at 1,2,3,4,5 minutes after propofol injection

7. phenylephrine injection if hypotension develops

Interventions

  • Device: leg wrapping with tension
    • Apply elastic bandages with tension to both legs before injecting propofol. After 3 minutes, remove elastic bandages.
  • Procedure: Trendelenburg position
    • Apply Trendelenburg position positon of 10 degree after injectin propofol After 3 minutes, change to supine position
  • Device: leg wrapping without tension
    • Apply elastic bandages without tension to both legs before injecting propofol. After 3 minutes, remove elastic bandages
  • Procedure: supine position
    • 1.maintain supine position

Arms, Groups and Cohorts

  • Active Comparator: Control
    • leg wrapping without tension & maintain supine position Apply elastic bandages to both legs without tension. Maintain supine position after injecting propofol. After 3 minutes from propofol injection, remove elastic bandages induction using propofol 2mg/kg After bispectral index (BIS) goes below 60 & patient become unconsciousness, inject rocuronium 0.6mg/kg intubate patient between 3 and 4 minutes after propofol injection measure blood pressure ( systolic, diastolic, mean ) & heart rate at 1,2,3,4,5 minutes after propofol injection phenylephrine injection if hypotension develops
  • Experimental: Trendelenburg only
    • leg wrapping without tension & apply Trendelenburg position Apply elastic bandages to both legs without tension. After injecting propofol, apply Trendelenburg position ( 10 degree ) After 3 minutes from propofol injection, remove elastic bandage and revert to supine position. induction using propofol 2mg/kg After bispectral index (BIS) goes below 60 & patient become unconsciousness, inject rocuronium 0.6mg/kg intubate patient between 3 and 4 minutes after propofol injection measure blood pressure ( systolic, diastolic, mean ) & heart rate at 1,2,3,4,5 minutes after propofol injection phenylephrine injection if hypotension develops
  • Experimental: Trendelenburg & leg wrapping
    • leg wrapping with tension & apply Trendelenburg position Apply elastic bandages to both legs with tension. After injecting propofol, apply Trendelenburg position ( 10 degree ) After 3 minutes from propofol injection, remove elastic bandage and revert to supine position. induction using propofol 2mg/kg After bispectral index (BIS) goes below 60 & patient become unconsciousness, inject rocuronium 0.6mg/kg intubate patient between 3 and 4 minutes after propofol injection measure blood pressure ( systolic, diastolic, mean ) & heart rate at 1,2,3,4,5 minutes after propofol injection phenylephrine injection if hypotension develops

Clinical Trial Outcome Measures

Primary Measures

  • SBP_2
    • Time Frame: 2 minutes from propofol injection
    • systolic blood pressure at 2 minutes from propofol injection

Participating in This Clinical Trial

Inclusion Criteria

  • American Society of Anesthesiologist's physiologic status class 1, 2, and 3.
  • under general anesthesia

Exclusion Criteria

  • severe cardiac/pulmonary/liver/renal disease
  • BMI > 30 kg/m2
  • known or risk factor of increased intraocular pressure or intracranial pressure
  • uncontrolled hypertension
  • high risk for propofol allergy
  • allergies to medications related to anesthesia
  • mechanical difficulties with leg wrapping ( wound on legs, devices on legs )
  • emergent operation
  • high risk of gastric aspiration ( gastrointestinal obstruction, short nil per os(NPO) time )
  • patient wearing elastic stocking for therapeutic purpose

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hyungmook Lee
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Hyungmook Lee, professor – Seoul St. Mary’s Hospital
  • Overall Official(s)
    • MiHyun Kim, Dr. PhD., Study Director, Department of anesthesia and pain medicine, Seoul St. Mary’s Hospital
  • Overall Contact(s)
    • Hyungmook Lee, Dr., 82-02-2258-6150, warmy0828@gmail.com

References

Sun HL, Ling QD, Sun WZ, Wu RS, Wu TJ, Wang SC, Chien CC. Lower limb wrapping prevents hypotension, but not hypothermia or shivering, after the introduction of epidural anesthesia for cesarean delivery. Anesth Analg. 2004 Jul;99(1):241-4.

Reuter DA, Felbinger TW, Schmidt C, Moerstedt K, Kilger E, Lamm P, Goetz AE. Trendelenburg positioning after cardiac surgery: effects on intrathoracic blood volume index and cardiac performance. Eur J Anaesthesiol. 2003 Jan;20(1):17-20.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.