Sedation DuringNCT01053611

Composite Variability Index Versus Bispectral Index (BIS)

A study testing propofol + remifentanil 0 ng/ml, propofol + remifentanil 2 ng/ml and propofol + remifentanil 4 ng/ml in people with Sedation During, run by University Medical Center Groningen 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

Search all trials

Trial summary

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sedation During
What is being tested?: propofol + remifentanil 0 ng/ml, propofol + remifentanil 2 ng/ml and propofol + remifentanil 4 ng/ml
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteNetherlands
Study dates: Sep 2009to Sep 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASA class I and II patients requiring general anesthesia for elective surgical procedures

Who cannot join

patient refusal
weight less than 70% or more than 130% of ideal body weight,
neurological disorder
recent use of psycho-active medication, including alcohol.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ

Other trials in Netherlands

About this study

Official title: Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion

Read the detailed description

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Conditions: Sedation During
Being tested: propofol + remifentanil 0 ng/ml, propofol + remifentanil 2 ng/ml, propofol + remifentanil 4 ng/ml, propofol + remifentanil 6 ng/ml
Keywords: composite variability index, bispectral index, pain
Medical subject headings: Pain

What participants receive

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

propofol + remifentanil 0 ng/mlDrug
remifentanil 0 ng/ml
propofol + remifentanil 2 ng/mlDrug
propofol + remifentanil 4 ng/mlDrug
propofol + remifentanil 6 ng/mlDrug
propofol + remifentanil 0 ng/mlDrug
propofol + remifentanil 2 ng/mlDrug
propofol + remifentanil 6 ng/mlDrug
propofol + remifentanil 6 ng/mlDrug
propofol + remifentanil 0 ng/mlDrug
propofol + remifentanil 2 ng/mlDrug
propofol + remifentanil 4 ng/mlDrug
propofol + remifentanil 6 ng/mlDrug

Study groups in NCT01053611
Study group	Role	What they receive
Group 1 BIS value 30	Active comparator	Not described Receives: Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 30	Active comparator	Not described Receives: Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 30	Active comparator	Not described Receives: Drug: propofol + remifentanil 4 ng/ml
Group 4 BIS valaue 30	Active comparator	Not described Receives: Drug: propofol + remifentanil 6 ng/ml
Group 1 BIS value 50	Active comparator	Not described Receives: Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 50	Active comparator	Not described Receives: Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 50	Active comparator	Not described Receives: Drug: propofol + remifentanil 6 ng/ml
Group 4 BIS value 50	Active comparator	Not described Receives: Drug: propofol + remifentanil 6 ng/ml
Group 1 BIS value 70	Active comparator	Not described Receives: Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 70	Active comparator	Not described Receives: Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 70	Active comparator	Not described Receives: Drug: propofol + remifentanil 4 ng/ml
Group 4 BIS value 70	Active comparator	Not described Receives: Drug: propofol + remifentanil 6 ng/ml

What is being measured

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

BIS and CVI.
Measured: 2 year

Timeline

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

Sep 2009Sep 2010

First posted21 Jan 2010 (estimated)
Study startSep 2009
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sedation DuringStudies of the same condition, open and under way.
More trials run by University Medical Center GroningenThe 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: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01053611
Sponsor's protocol ID: 2009.083
Status last verified: Sep 2009
First submitted: 20 Jan 2010
Last updated: 25 Mar 2011
Results posted: No
Data monitoring committee: No

Publications

Sahinovic MM, Eleveld DJ, Kalmar AF, Heeremans EH, De Smet T, Seshagiri CV, Absalom AR, Vereecke HEM, Struys MMRF. Accuracy of the composite variability index as a measure of the balance between nociception and antinociception during anesthesia. Anesth Analg. 2014 Aug;119(2):288-301. doi: 10.1213/ANE.0000000000000274.
PubMed 24892803

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?

See locations

RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Recruiting
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
Hip Arthroplasty, Spinal Anesthesia
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)

All Sedation During trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion
ClinicalTrials.gov ID: NCT01053611
Acronym / sponsor ID: 2009.083
Conditions: Sedation During
Keywords: composite variability index, bispectral index, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: University Medical Center GroningenUniversity, hospital or other
Study start: Sep 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 21 Jan 2010 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Group 1 BIS value 30	Active comparator	Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 30	Active comparator	Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 30	Active comparator	Drug: propofol + remifentanil 4 ng/ml
Group 4 BIS valaue 30	Active comparator	Drug: propofol + remifentanil 6 ng/ml
Group 1 BIS value 50	Active comparator	Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 50	Active comparator	Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 50	Active comparator	Drug: propofol + remifentanil 6 ng/ml
Group 4 BIS value 50	Active comparator	Drug: propofol + remifentanil 6 ng/ml
Group 1 BIS value 70	Active comparator	Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 70	Active comparator	Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 70	Active comparator	Drug: propofol + remifentanil 4 ng/ml
Group 4 BIS value 70	Active comparator	Drug: propofol + remifentanil 6 ng/ml

Who may qualify

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

Key inclusion criteria (1 listed)

ASA class I and II patients requiring general anesthesia for elective surgical procedures

Key exclusion criteria (4 listed)

patient refusal
weight less than 70% or more than 130% of ideal body weight,
neurological disorder
recent use of psycho-active medication, including alcohol.

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
propofol + remifentanil 0 ng/mlremifentanil 0 ng/ml	Drug	Group 1 BIS value 30
propofol + remifentanil 2 ng/ml	Drug	Group 2 BIS value 30
propofol + remifentanil 4 ng/ml	Drug	Group 3 BIS value 30
propofol + remifentanil 6 ng/ml	Drug	Group 4 BIS valaue 30
propofol + remifentanil 0 ng/ml	Drug	Group 1 BIS value 50
propofol + remifentanil 2 ng/ml	Drug	Group 2 BIS value 50
propofol + remifentanil 6 ng/ml	Drug	Group 3 BIS value 50
propofol + remifentanil 6 ng/ml	Drug	Group 4 BIS value 50
propofol + remifentanil 0 ng/ml	Drug	Group 1 BIS value 70
propofol + remifentanil 2 ng/ml	Drug	Group 2 BIS value 70
propofol + remifentanil 4 ng/ml	Drug	Group 3 BIS value 70
propofol + remifentanil 6 ng/ml	Drug	Group 4 BIS value 70

Primary outcome

BIS and CVI.
Time frame: 2 year

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 25 Mar 2011.
Derived from this study: PubMed 24892803Sahinovic MM, Eleveld DJ, Kalmar AF, Heeremans EH, De Smet T, Seshagiri CV, Absalom AR, Vereecke HEM, Struys MMRF. Accuracy of the composite variability index as a measure of the balance between nociception and antinociception during anesthesia. Anesth Analg. 2014 Aug;119(2):288-301. doi: 10.1213/ANE.0000000000000274.

Related trials for Sedation During

RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Recruiting
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
Hip Arthroplasty, Spinal Anesthesia
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)

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 4 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 25 Mar 2011. 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?

BIS and CVI. (time frame: 2 year). 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 NCT01053611, which also lists 1 linked publication.

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 25 Mar 2011.