NCT03074955

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

February 26, 2017

Last Update Submit

March 5, 2017

Conditions

HypotensionPropofol

Keywords

HypotensionPropofolTrendelenburgleg wrapping

Outcome Measures

Primary Outcomes (1)

  • SBP_2

    systolic blood pressure at 2 minutes from propofol injection

    2 minutes from propofol injection

Study Arms (3)

Control

ACTIVE COMPARATOR

leg wrapping without tension \& maintain supine position 1. Apply elastic bandages to both legs without tension. 2. Maintain supine position after injecting propofol. 3. After 3 minutes from propofol injection, remove elastic bandages 4. induction using propofol 2mg/kg 5. After bispectral index (BIS) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg 6. intubate patient between 3 and 4 minutes after propofol injection 7. measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection 8. phenylephrine injection if hypotension develops

Device: leg wrapping without tensionProcedure: supine position

Trendelenburg only

EXPERIMENTAL

leg wrapping without tension \& apply Trendelenburg position 1. Apply elastic bandages to both legs without tension. 2. After injecting propofol, apply Trendelenburg position ( 10 degree ) 3. After 3 minutes from propofol injection, remove elastic bandage and revert to supine position. 4. induction using propofol 2mg/kg 5. After bispectral index (BIS) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg 6. intubate patient between 3 and 4 minutes after propofol injection 7. measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection 8. phenylephrine injection if hypotension develops

Procedure: Trendelenburg positionProcedure: supine position

Trendelenburg & leg wrapping

EXPERIMENTAL

leg wrapping with tension \& apply Trendelenburg position 1. Apply elastic bandages to both legs with tension. 2. After injecting propofol, apply Trendelenburg position ( 10 degree ) 3. After 3 minutes from propofol injection, remove elastic bandage and revert to supine position. 4. induction using propofol 2mg/kg 5. After bispectral index (BIS) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg 6. intubate patient between 3 and 4 minutes after propofol injection 7. measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection 8. phenylephrine injection if hypotension develops

Device: leg wrapping with tensionProcedure: Trendelenburg position

Interventions

leg wrapping with tensionDEVICE

1. Apply elastic bandages with tension to both legs before injecting propofol. 2. After 3 minutes, remove elastic bandages.

Trendelenburg & leg wrapping
Trendelenburg positionPROCEDURE

1. Apply Trendelenburg position positon of 10 degree after injectin propofol 2. After 3 minutes, change to supine position

Trendelenburg & leg wrappingTrendelenburg only
leg wrapping without tensionDEVICE

1. Apply elastic bandages without tension to both legs before injecting propofol. 2. After 3 minutes, remove elastic bandages

Control
supine positionPROCEDURE

1.maintain supine position

ControlTrendelenburg only

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seo-Cho Gu, 06591, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15281537BACKGROUND

  • 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.

    PMID: 12553383BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Head-Down TiltSupine Position

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • MiHyun Kim, Dr. PhD.

    Department of anesthesia and pain medicine, Seoul St. Mary's Hospital

    STUDY DIRECTOR

Central Study Contacts

Hyungmook Lee, Dr.

CONTACT

82-02-2258-6150warmy0828@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 9, 2017

Study Start

August 16, 2013

Primary Completion

July 31, 2018

Study Completion

December 31, 2018

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)