HypotensionNCT03074955
Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol
A study testing leg wrapping with tension, Trendelenburg position and leg wrapping without tension in people with Hypotension and Propofol, run by Hyungmook Lee at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypotension, Propofol
- What is being tested?
- leg wrapping with tension, Trendelenburg position and leg wrapping without tension
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic status class 1, 2, and 3.
- under general anesthesia
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul, Seo-Cho Gu, 06591
Hyungmook Lee, Dr.
About this study
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.
Read the detailed description
** Study procedure
- check baseline blood pressure ( systolic, diastolic, mean) and heart rate.
- apply pre-defined measures to each group(arm) ( summarized in arms and interventions section )
- induction using propofol 2mg/kg
- After bispectral index (BIS) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg
- intubate patient between 3 and 4 minutes after propofol injection
- measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection
- phenylephrine injection if hypotension develops
- Conditions
- Hypotension, Propofol
- Being tested
- leg wrapping with tension, Trendelenburg position, leg wrapping without tension, supine position
- Keywords
- Hypotension, Propofol, Trendelenburg, leg wrapping
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg wrapping with tensionDevice
- Apply elastic bandages with tension to both legs before injecting propofol.
- After 3 minutes, remove elastic bandages.
Trendelenburg positionProcedure or surgery
- Apply Trendelenburg position positon of 10 degree after injectin propofol
- After 3 minutes, change to supine position
leg wrapping without tensionDevice
- Apply elastic bandages without tension to both legs before injecting propofol.
- After 3 minutes, remove elastic bandages
supine positionProcedure or surgery
1.maintain supine position
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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 Receives: Device: leg wrapping without tension; Procedure: supine position |
| Trendelenburg only | Experimental | 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 Receives: Procedure: Trendelenburg position; Procedure: supine position |
| Trendelenburg & leg wrapping | Experimental | 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 Receives: Device: leg wrapping with tension; Procedure: Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBP_2
systolic blood pressure at 2 minutes from propofol injection
Measured: 2 minutes from propofol injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start16 Aug 2013
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyungmook Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyungmook Lee, Seoul St. Mary's Hospital
- Investigators
- MiHyun Kim, Dr. PhD., Study director, Department of anesthesia and pain medicine, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074955
- Sponsor's protocol ID
- B1304200001
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15281537Reuter 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.
PubMed 12553383
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol
- ClinicalTrials.gov ID
- NCT03074955
- Acronym / sponsor ID
- B1304200001
- Conditions
- Hypotension, Propofol
- Keywords
- Hypotension, Propofol, Trendelenburg, leg wrapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Hyungmook LeeUniversity, hospital or other
- Study start
- 16 Aug 2013 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- check baseline blood pressure ( systolic, diastolic, mean) and heart rate.
- apply pre-defined measures to each group(arm) ( summarized in arms and interventions section )
- induction using propofol 2mg/kg
- After bispectral index (BIS) goes below 60 \& patient become unconsciousness, inject rocuronium 0.6mg/kg
- intubate patient between 3 and 4 minutes after propofol injection
- measure blood pressure ( systolic, diastolic, mean ) \& heart rate at 1,2,3,4,5 minutes after propofol injection
- phenylephrine injection if hypotension develops
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: leg wrapping without tension, Procedure: supine positionleg 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 | Experimental | Procedure: Trendelenburg position, Procedure: supine positionleg 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 | Experimental | Device: leg wrapping with tension, Procedure: Trendelenburg positionleg 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist's physiologic status class 1, 2, and 3.
- under general anesthesia
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leg wrapping with tension1. Apply elastic bandages with tension to both legs before injecting propofol. 2. After 3 minutes, remove elastic bandages. | Device | Trendelenburg & leg wrapping |
| Trendelenburg position1. Apply Trendelenburg position positon of 10 degree after injectin propofol 2. After 3 minutes, change to supine position | Procedure or surgery | Trendelenburg & leg wrapping, Trendelenburg only |
| leg wrapping without tension1. Apply elastic bandages without tension to both legs before injecting propofol. 2. After 3 minutes, remove elastic bandages | Device | Control |
| supine position1.maintain supine position | Procedure or surgery | Control, Trendelenburg only |
Primary outcome
SBP_2
Time frame: 2 minutes from propofol injection
systolic blood pressure at 2 minutes from propofol injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Background: PubMed 15281537Sun 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.
- Background: PubMed 12553383Reuter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MiHyun Kim, Dr. PhD. study director
Department of anesthesia and pain medicine, Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg wrapping with tension, Trendelenburg position and leg wrapping without tension in people with Hypotension and Propofol, run by Hyungmook Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyungmook Lee, Dr. (82-02-2258-6150, warmy0828@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBP_2 (time frame: 2 minutes from propofol injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.