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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03074955
Enrollment
156
Registered
2017-03-09
Start date
2013-08-16
Completion date
2018-12-31
Last updated
2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Propofol

Keywords

Hypotension, Propofol, Trendelenburg, leg wrapping

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 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

DEVICEleg wrapping with tension

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

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

DEVICEleg wrapping without tension

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

PROCEDUREsupine position

1.maintain supine position

Sponsors

Hyungmook Lee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SBP_22 minutes from propofol injectionsystolic blood pressure at 2 minutes from propofol injection

Countries

South Korea

Contacts

Primary ContactHyungmook Lee, Dr.
warmy0828@gmail.com82-02-2258-6150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026