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

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 Overview

• Status: Unknown
• Conditions: Hypotension; Propofol
• Intervention / Treatment: Device: leg wrapping without tension; Procedure: supine position; Procedure: Trendelenburg position; Device: leg wrapping with tension

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

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seo-Cho Gu
    • Seoul, Seo-Cho Gu, Korea, Republic of, 06591
      • Recruiting
      • Seoul St. Mary's Hospital
      • Contact: Hyungmook Lee, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	Procedure: supine position; 1.maintain supine position; Procedure: Trendelenburg position; Apply Trendelenburg position positon of 10 degree after injectin propofol; After 3 minutes, change to supine position
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	Procedure: Trendelenburg position; Apply Trendelenburg position positon of 10 degree after injectin propofol; After 3 minutes, change to supine position; Device: leg wrapping with tension; Apply elastic bandages with tension to both legs before injecting propofol.; After 3 minutes, remove elastic bandages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP_2	systolic blood pressure at 2 minutes from propofol injection	2 minutes from propofol injection

Collaborators and Investigators

• Sponsor: Hyungmook Lee
• Investigators: Study Director: MiHyun Kim, Dr. PhD., Department of anesthesia and pain medicine, Seoul St. Mary's Hospital

Publications and helpful links

General Publications

• 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):241-245. doi: 10.1213/01.ANE.0000121346.33443.5A.
• 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. doi: 10.1017/s0265021503000036.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2013
• Primary Completion (Anticipated): July 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: February 26, 2017
• First Submitted That Met QC Criteria: March 5, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 5, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Hypotension; Propofol; Trendelenburg; leg wrapping
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: B1304200001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No