Cardiac IndexNCT02249585

Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position

A study testing Standard abdominal pressure, Low abdominal pressure and Conventional neuromuscular blockade in people with Cardiac Index, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Cardiac Index
What is being tested?: Standard abdominal pressure, Low abdominal pressure and Conventional neuromuscular blockade
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 1 siteSouth Korea
Study dates: Sep 2014to Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients scheduled for laparoscopic colon surgery under Trendelenberg position

Who cannot join

ASA classification IV
Unable to make a written, informed consent
Allergic to neuromuscular blocking agents, anesthetics, opioids
Patients with neuromuscular disease
Hepatic failure
Renal failure

Show all 9Show fewer

History of malignant hyperthermia
Morbid obesity with BMI>35 kg/m2
Patients enrolled in another clinical trials

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

About this study

The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.

Conditions: Cardiac Index
Being tested: Standard abdominal pressure, Low abdominal pressure, Conventional neuromuscular blockade, Deep neuromuscular blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard abdominal pressureDevice
Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
Low abdominal pressureDevice
Also called Abdominal pressure
Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery
Conventional neuromuscular blockadeDrug
Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch
Deep neuromuscular blockadeDrug
Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch

Study groups in NCT02249585
Study group	Role	What they receive
CS	Experimental	Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure. Receives: Device: Standard abdominal pressure; Drug: Conventional neuromuscular blockade
DS	Experimental	Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure. Receives: Device: Standard abdominal pressure; Drug: Deep neuromuscular blockade
DL	Experimental	Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure. Receives: Device: Low abdominal pressure; Drug: Deep neuromuscular blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Index
Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
Measured: 30 min after onset of laparoscopy

Secondary outcomes (5)

Mean Arterial Blood Pressure (MBP)
Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
Measured: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
Stroke Volume Index (SVI)
Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
Measured: 1, 30, 60, 90, 120 min after onset of laparoscopy
PaO2
PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).
Measured: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
Pulmonary Compliance
Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).
Measured: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
Surgical Rating Scale
The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.
Measured: 1 min after laparoscopic procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Oct 2016

First posted25 Sep 2014 (estimated)
Study startSep 2014
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac IndexStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
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: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02249585
Sponsor's protocol ID: 1405-010-576
Status last verified: Nov 2017
First submitted: 19 Sep 2014
Last updated: 6 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position
ClinicalTrials.gov ID: NCT02249585
Acronym / sponsor ID: 1405-010-576
Conditions: Cardiac Index
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Sep 2014 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 6 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
CS	Experimental	Device: Standard abdominal pressure, Drug: Conventional neuromuscular blockadePatients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
DS	Experimental	Device: Standard abdominal pressure, Drug: Deep neuromuscular blockadePatients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
DL	Experimental	Device: Low abdominal pressure, Drug: Deep neuromuscular blockadePatients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients scheduled for laparoscopic colon surgery under Trendelenberg position

Key exclusion criteria (9 listed)

ASA classification IV
Unable to make a written, informed consent
Allergic to neuromuscular blocking agents, anesthetics, opioids
Patients with neuromuscular disease
Hepatic failure

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
Standard abdominal pressureAbdominal pressure maintained 12mmHg throughout laparoscopic colon surgery	Device	CS, DS
Low abdominal pressureAlso: Abdominal pressureAbdominal pressure maintained 8mmHg throughout laparoscopic colon surgery	Device	DL
Conventional neuromuscular blockadeAnesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch	Drug	CS
Deep neuromuscular blockadeAnesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch	Drug	DL, DS

Primary outcome

Cardiac Index
Time frame: 30 min after onset of laparoscopy
Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.

5 secondary outcomes

Mean Arterial Blood Pressure (MBP)
Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
Stroke Volume Index (SVI)
Time frame: 1, 30, 60, 90, 120 min after onset of laparoscopy
PaO2
Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
Pulmonary Compliance
Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
Surgical Rating Scale
Time frame: 1 min after laparoscopic procedure

Results and safety

Results posted to the registry on 6 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CS(Conventional Block With Standard Pressure)	43	43
DS(Deep Block With Standard Pressure)	44	44
DL(Deep Block With Low Pressure)	44	44

Primary outcome: Cardiac Index

Time frame: 30 min after onset of laparoscopy. Mean (Standard Deviation). Unit: L/min/m^2

Measure	CS(Conventional Block With Standard Pressure) n = 43	DS(Deep Block With Standard Pressure) n = 44	DL(Deep Block With Low Pressure) n = 44
Value	2.6 (1.0)	2.7 (0.9)	2.7 (0.7)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CS(Conventional Block With Standard Pressure)	0 of 43 (0%)	0 of 43 (0%)	Not reported
DS(Deep Block With Standard Pressure)	0 of 44 (0%)	0 of 44 (0%)	Not reported
DL(Deep Block With Low Pressure)	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 9 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: finished, as of the sponsor's last update on 6 Aug 2018. 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?

Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Index (time frame: 30 min after onset of laparoscopy). 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 NCT02249585.

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 6 Aug 2018.