NCT03074955

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Hyungmook Lee · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypotension
• Propofol

Interventions

Type	Name	Description
DEVICE	leg wrapping with tension	1. Apply elastic bandages with tension to both legs before injecting propofol. 2. After 3 minutes, remove elastic bandages.
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 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

Timeline

• Start date: 2013-08-16
• Primary completion: 2018-07-31
• Completion: 2018-12-31
• First posted: 2017-03-09
• Last updated: 2017-03-09

Locations

1 site across 1 country: South Korea