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

March 5, 2017 updated by: Hyungmook Lee
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control

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 tension
  1. Apply elastic bandages without tension to both legs before injecting propofol.
  2. After 3 minutes, remove elastic bandages
Procedure: supine position
1.maintain supine position
Experimental: Trendelenburg only

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: supine position
1.maintain supine position
Procedure: Trendelenburg position
  1. Apply Trendelenburg position positon of 10 degree after injectin propofol
  2. After 3 minutes, change to supine position
Experimental: Trendelenburg & leg wrapping

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
Procedure: Trendelenburg position
  1. Apply Trendelenburg position positon of 10 degree after injectin propofol
  2. After 3 minutes, change to supine position
Device: leg wrapping with tension
  1. Apply elastic bandages with tension to both legs before injecting propofol.
  2. After 3 minutes, remove elastic bandages.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SBP_2
Time Frame: 2 minutes from propofol injection
systolic blood pressure at 2 minutes from propofol injection
2 minutes from propofol injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hyungmook Lee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MiHyun Kim, Dr. PhD., Department of anesthesia and pain medicine, Seoul St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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