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

Not Applicable

• Conditions: Hypotension; Propofol
• Interventions: Device: leg wrapping without tension; Procedure: Trendelenburg position; Device: leg wrapping with tension; Procedure: supine position

• Registration Number: NCT03074955
• Lead Sponsor: Hyungmook Lee

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

Study Timeline

• Study Start: 2013-08-16
• Study First Submitted: 2017-02-26
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-05
• Last Update Submitted: 2017-03-05
• Study First Posted: 2017-03-09
• Last Update Posted: 2017-03-09
• Primary Completion: 2018-07-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	supine position	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
Control	leg wrapping without tension	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
Trendelenburg only	Trendelenburg position	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
Trendelenburg only	supine position	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
Trendelenburg & leg wrapping	Trendelenburg position	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
Trendelenburg & leg wrapping	leg wrapping with tension	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

Primary Outcome Measures

Name	Time	Method
SBP_2	2 minutes from propofol injection	systolic blood pressure at 2 minutes from propofol injection

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seo-Cho Gu, Korea, Republic of