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

Primary Purpose

Hypotension, Propofol

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
leg wrapping with tension
Trendelenburg position
leg wrapping without tension
supine position
Sponsored by
Hyungmook Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Hypotension, Propofol, Trendelenburg, leg wrapping

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Trendelenburg only

Trendelenburg & leg wrapping

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

SBP_2
systolic blood pressure at 2 minutes from propofol injection

Secondary Outcome Measures

Full Information

First Posted
February 26, 2017
Last Updated
March 5, 2017
Sponsor
Hyungmook Lee
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1. Study Identification

Unique Protocol Identification Number
NCT03074955
Brief Title
Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol
Official Title
Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2013 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyungmook Lee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
** Study procedure check baseline blood pressure ( systolic, diastolic, mean) and heart rate. apply pre-defined measures to each group(arm) ( summarized in arms and interventions section ) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Propofol
Keywords
Hypotension, Propofol, Trendelenburg, leg wrapping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Trendelenburg only
Arm Type
Experimental
Arm Description
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
Arm Title
Trendelenburg & leg wrapping
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
leg wrapping with tension
Intervention Description
Apply elastic bandages with tension to both legs before injecting propofol. After 3 minutes, remove elastic bandages.
Intervention Type
Procedure
Intervention Name(s)
Trendelenburg position
Intervention Description
Apply Trendelenburg position positon of 10 degree after injectin propofol After 3 minutes, change to supine position
Intervention Type
Device
Intervention Name(s)
leg wrapping without tension
Intervention Description
Apply elastic bandages without tension to both legs before injecting propofol. After 3 minutes, remove elastic bandages
Intervention Type
Procedure
Intervention Name(s)
supine position
Intervention Description
1.maintain supine position
Primary Outcome Measure Information:
Title
SBP_2
Description
systolic blood pressure at 2 minutes from propofol injection
Time Frame
2 minutes from propofol injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyungmook Lee, Dr.
Phone
82-02-2258-6150
Email
warmy0828@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MiHyun Kim, Dr. PhD.
Organizational Affiliation
Department of anesthesia and pain medicine, Seoul St. Mary's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Seo-Cho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyungmook Lee, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15281537
Citation
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.
Results Reference
background
PubMed Identifier
12553383
Citation
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.
Results Reference
background

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

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