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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074955
• Other study ID #: B1304200001
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2017
• Last updated: March 5, 2017
• Start date: August 16, 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2017
• Source: Seoul St. Mary's Hospital
• Contact: Hyungmook Lee, Dr.
• Phone: 82-02-2258-6150
• Email: warmy0828[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Propofol

Intervention

Device:
• leg wrapping with tension
Apply elastic bandages with tension to both legs before injecting propofol. After 3 minutes, remove elastic bandages.

Procedure:
• Trendelenburg position
Apply Trendelenburg position positon of 10 degree after injectin propofol After 3 minutes, change to supine position

Device:
• leg wrapping without tension
Apply elastic bandages without tension to both legs before injecting propofol. After 3 minutes, remove elastic bandages

Procedure:
• supine position
1.maintain supine position

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Seo-Cho Gu

Sponsors (1)

Lead Sponsor	Collaborator
Hyungmook Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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):241-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SBP_2	systolic blood pressure at 2 minutes from propofol injection	2 minutes from propofol injection