Clinical trial NCT03074955: Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol
Official title: Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Propofol
Keywords: Hypotension
Propofol
Trendelenburg
leg wrapping
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: SBP_2
timeFrame: 2 minutes from propofol injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seo-Cho Gu
Study officials:
affiliation: Department of anesthesia and pain medicine, Seoul St. Mary's Hospital
name: MiHyun Kim, Dr. PhD.
role: STUDY_DIRECTOR
References:
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):241-245. doi: 10.1213/01.ANE.0000121346.33443.5A.
citation: 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.