PainNCT01912118

The Medasense Study

A study testing Propofol and Remifentanil in people with Pain, run by Leiden University Medical Center at 1 site in Netherlands.

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 18 to 80 years
Conditions the study is for: Pain
What is being tested?: Propofol and Remifentanil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteNetherlands
Study dates: Jul 2013to Sep 2014
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

Age: 18-80 years;
Sex: male or female;
Surgery: Any surgery under general anesthesia;
ASA status: 1, 2 or 3.

Who cannot join

Age: < 18 or > 80 years;
Unable to give written informed consent;
Pregnancy/lactation;
Extreme obesity: BMI > 35;
Perceived difficult intubation.
Patients requiring a rapid sequence induction
Patients on beta-blockers

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Leiden University Medical Center
Leiden

Other trials in Netherlands

About this study

Official title: Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index

Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.

Conditions: Pain
Being tested: Propofol, Remifentanil
Keywords: Nociception, General anesthesia
Medical subject headings: Pain

What participants receive

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

PropofolDrug
Also called Diprivan
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
RemifentanilDrug
Also called Ultiva
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)

Study groups in NCT01912118
Study group	Role	What they receive
PROPOFOL ONLY GROUP	Experimental	In this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5-min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5-min the laryngoscope will be placed again and the patient will be intubated. This will be done without additional administration of muscle relaxant. Receives: Drug: Propofol
PROPOFOL + REMIFENTANIL TARGET A	Experimental	The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil. Receives: Drug: Propofol; Drug: Remifentanil
PROPOFOL + REMIFENTANIL TARGET B	Experimental	The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil Receives: Drug: Propofol; Drug: Remifentanil
PROPOFOL + REMIFENTANIL TARGET C	Experimental	The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil. Receives: Drug: Propofol; Drug: Remifentanil
PROPOFOL + REMIFENTANIL TARGET D	Experimental	The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil. Receives: Drug: Propofol; Drug: Remifentanil
PROPOFOL + REMIFENTANIL TARGET E	Experimental	The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil. Receives: Drug: Propofol; Drug: Remifentanil
PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C	Experimental	The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30. Receives: Drug: Propofol; Drug: Remifentanil
PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C	Experimental	The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70. Receives: Drug: Propofol; Drug: Remifentanil

What is being measured

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

Nociception level index (NoI)
The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.
Measured: Between induction and first incision

Secondary outcomes (3)

Cardiovascular parameters
Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.
Measured: Between induction and first incision
Movement
Visible occurence of movement during painfull stimuli.
Measured: Between induction and first incision
Depth of anesthesia
Depth of anesthesia is measured by a Bispectral Index monitor. Changes in depth of anesthesia will be recorded during painfull stimuli
Measured: Between induction and first incision

Timeline

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

Jul 2013Sep 2014

First posted30 Jul 2013 (estimated)
Study startJul 2013
Primary completionJun 2014
Study completionSep 2014

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 PainStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01912118
Sponsor's protocol ID: NL43511.058.13
Status last verified: Apr 2015
First submitted: 25 Jul 2013
Last updated: 6 Apr 2015
Results posted: No
Data monitoring committee: Yes

Publications

Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
PubMed 22647429
Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
PubMed 23835792

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 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index
ClinicalTrials.gov ID: NCT01912118
Acronym / sponsor ID: NL43511.058.13
Conditions: Pain
Keywords: Nociception, General anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Leiden University Medical CenterUniversity, hospital or other
Collaborators: Medasense Biometrics Ltd
Study start: Jul 2013
Primary completion: Jun 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 30 Jul 2013 (estimated)
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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
PROPOFOL ONLY GROUP	Experimental	Drug: PropofolIn this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5-min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5-min the laryngoscope will be placed again and the patient will be intubated. This will be done without additional administration of muscle relaxant.
PROPOFOL + REMIFENTANIL TARGET A	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil.
PROPOFOL + REMIFENTANIL TARGET B	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil
PROPOFOL + REMIFENTANIL TARGET C	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil.
PROPOFOL + REMIFENTANIL TARGET D	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil.
PROPOFOL + REMIFENTANIL TARGET E	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil.
PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30.
PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C	Experimental	Drug: Propofol, Drug: RemifentanilThe subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age: 18-80 years;
Sex: male or female;
Surgery: Any surgery under general anesthesia;
ASA status: 1, 2 or 3.

Key exclusion criteria (7 listed)

Age: < 18 or > 80 years;
Unable to give written informed consent;
Pregnancy/lactation;
Extreme obesity: BMI > 35;
Perceived difficult intubation.

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
PropofolAlso: DiprivanPropofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)	Drug	PROPOFOL + REMIFENTANIL TARGET A, PROPOFOL + REMIFENTANIL TARGET B, PROPOFOL + REMIFENTANIL TARGET C, PROPOFOL + REMIFENTANIL TARGET D, PROPOFOL + REMIFENTANIL TARGET E, PROPOFOL ONLY GROUP, PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C, PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C
RemifentanilAlso: UltivaRemifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)	Drug	PROPOFOL + REMIFENTANIL TARGET A, PROPOFOL + REMIFENTANIL TARGET B, PROPOFOL + REMIFENTANIL TARGET C, PROPOFOL + REMIFENTANIL TARGET D, PROPOFOL + REMIFENTANIL TARGET E, PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C, PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C

Primary outcome

Nociception level index (NoI)
Time frame: Between induction and first incision
The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.

3 secondary outcomes

Cardiovascular parameters
Time frame: Between induction and first incision
Movement
Time frame: Between induction and first incision
Depth of anesthesia
Time frame: Between induction and first incision

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
Background: PubMed 22647429Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
Background: PubMed 23835792Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.

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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.

Albert Dahan, MD, PhD, Professor principal investigator

Leiden University Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing Propofol and Remifentanil in people with Pain, run by Leiden University Medical Center at 1 site in Netherlands.

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 4 inclusion and 7 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 Apr 2015. 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 Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Nociception level index (NoI) (time frame: Between induction and first incision). 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 NCT01912118, 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 6 Apr 2015.