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

NCT ID: NCT03074955

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-16
• Study Completion Date: 2018-12-31

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

Conditions

Hypotension; Propofol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

leg wrapping without tension

Intervention Type: DEVICE

1. Apply elastic bandages without tension to both legs before injecting propofol.

2. After 3 minutes, remove elastic bandages

supine position

Intervention Type: PROCEDURE

1.maintain supine position

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

Group Type: EXPERIMENTAL

Trendelenburg position

Intervention Type: PROCEDURE

1. Apply Trendelenburg position positon of 10 degree after injectin propofol

2. After 3 minutes, change to supine position

supine position

Intervention Type: PROCEDURE

1.maintain supine position

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

Group Type: EXPERIMENTAL

leg wrapping with tension

Intervention Type: DEVICE

1. Apply elastic bandages with tension to both legs before injecting propofol.

2. After 3 minutes, remove elastic bandages.

Trendelenburg position

Intervention Type: PROCEDURE

1. Apply Trendelenburg position positon of 10 degree after injectin propofol

2. After 3 minutes, change to supine position

Interventions

leg wrapping with tension

1. Apply elastic bandages with tension to both legs before injecting propofol.

2. After 3 minutes, remove elastic bandages.

Intervention Type: DEVICE

Trendelenburg position

1. Apply Trendelenburg position positon of 10 degree after injectin propofol

2. After 3 minutes, change to supine position

Intervention Type: PROCEDURE

leg wrapping without tension

1. Apply elastic bandages without tension to both legs before injecting propofol.

2. After 3 minutes, remove elastic bandages

Intervention Type: DEVICE

supine position

1.maintain supine position

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyungmook Lee

OTHER

Sponsor Role: lead

Responsible Party

Hyungmook Lee

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

MiHyun Kim, Dr. PhD.

Role: STUDY_DIRECTOR

Department of anesthesia and pain medicine, Seoul St. Mary's Hospital

Locations

Seoul St. Mary's Hospital

Seoul, Seo-Cho Gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyungmook Lee, Dr.

Role: CONTACT

warmy0828@gmail.com

82-02-2258-6150

Facility Contacts

Hyungmook Lee, Dr.

Role: primary

References

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):241-245. doi: 10.1213/01.ANE.0000121346.33443.5A.

Reference Type: BACKGROUND

PMID: 15281537 (View on PubMed)

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. doi: 10.1017/s0265021503000036.

Reference Type: BACKGROUND

PMID: 12553383 (View on PubMed)

Other Identifiers

B1304200001

Identifier Type: -

Identifier Source: org_study_id