AnesthesiaNCT01450813
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
A study testing Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg and Rocuronium 0.4 mg/kg in people with Anesthesia and Neuromuscular Blockade, run by Medtronic - MITG at 1 site in United States.
Trial summary
The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness. The Composite Variability Index (CVI) is a new index that may provide the anesthesiologist with more information about the condition of the patient. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Neuromuscular Blockade
- What is being tested?
- Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg and Rocuronium 0.4 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesia (ASA) physical status class I or II.
- Body mass index between 18 and 35 kg m-2.
- No use of psychotropic or neuropsychiatric medications.
- A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
- Age between 18-75 years.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fletcher Allen Health Care
Burlington, Vermont, 05405
About this study
Official title: The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy
The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness. The Composite Variability Index (CVI) is a new index that may provide the anesthesiologist with more information about the condition of the patient. The CVI is a measure of the combined variability in BIS (bispectral index) and frontal electromyography (EMG) activity that may be useful in assessing the nociception/anti-nociception balance for patients under general anesthesia.The purpose of this study is to determine if a commonly used anesthetic drug (rocuronium) affects the CVI measurement differently with different doses. Rocuronium is a neuromuscular blocking agent (NMBA) routinely used during surgery. It is expected that the group given the highest dose of rocuronium will have diminished CVI values.
This study will randomize patients to one of four doses of rocuronium: no rocuronium, 0.2, 0.4, and 0.6 milligrams per kilo of body weight; the last dose is the standard amount for adults. It is expected that the group given the highest dose of rocuronium will have diminished CVI values. By including intermediate doses, information about the function of CVI in states of less than full muscle relaxation, or paralysis, will be obtained. This information is critically important for the development of the composite variability index, because during general anesthesia patients are usually maintained in a state of less than full paralysis. If the CVI response to stimulation in the intermediate groups is similar to the group receiving no rocuronium, the monitor may find wide clinical applicability. If the response is similar to the maximal rocuronium group, the index may only be reliable in states with no muscle relaxant, which will greatly limit clinical utility.
Read the detailed description
Consented subjects randomized to one of four doses of rocuronium will be transported to the operating room and be connected to routine monitors that included a BIS (Covidien), M-Entropy sensor (GE Healthcare) and TOF (train of four) monitor. Following preoxygenation, general anesthesia will be induced with propofol and remifentanil using traditional syringe pumps. The induction doses given and subsequent infusion rates will be determined by utilizing pharmacokinetic (Pk) models (Marsh model for propofol, Minto model for remifentanil). Unconsciousness will be confirmed by performing the usual clinical assessments and by obtaining a BIS value between 40 and 50. Once the subject is unconsciousness, they will be given the assigned dose of rocuronium, after which the study anesthesiologist will perform a laryngoscopy. The anesthesiologist performing the laryngoscopy will not know what dose of rocuronium the subject received. Neuromuscular blockade (NMB) will be monitored by a train-of-four twitch monitor (TOF Watch-SX) at the adductor pollicis muscle (2 HZ, 50mAmp) every 15 seconds.
At three minutes after the rocuronium administration, a standardized 20-second laryngoscopy will be applied. The CVI, entropy, and hemodynamic responses (heart rate, blood pressure measurement each minute) and train-of-four measurements will be monitored for three minutes before and after the laryngoscopy.
- Conditions
- Anesthesia, Neuromuscular Blockade
- Being tested
- Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg, Rocuronium 0.4 mg/kg, Rocuronium 0.6 mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline 0.06 ml/kgDrug
Also called Normal Saline
IV Infusion x1 prior to laryngoscopy
Rocuronium 0.2 mg/kgDrug
Also called Rocuronium bromide: Zemuron
IV Infusion x1 prior to laryngoscopy
Rocuronium 0.4 mg/kgDrug
Also called Rocuronium bromide: Zemuron
IV Infusion x1 prior to laryngoscopy
Rocuronium 0.6 mg/kgDrug
Also called Rocuronium bromide: Zemuron
IV Infusion x1 prior to laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sham comparator | Saline 0.06 ml/kg Receives: Drug: Saline 0.06 ml/kg |
| Group 2 | Active comparator | Rocuronium 0.2 mg/kg Receives: Drug: Rocuronium 0.2 mg/kg |
| Group 3 | Active comparator | Rocuronium 0.4 mg/kg Receives: Drug: Rocuronium 0.4 mg/kg |
| Group 4 | Active comparator | Rocuronium 0.6 mg/kg Receives: Drug: Rocuronium 0.6 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups
The difference between the mean CVI in three minutes prior to laryngoscopy and three minutes following laryngoscopy reported as the mean change in CVI and the +/- 95% confidence interval for each group.
The Composite Variability Index (CVI) scale is a logistic regression of three measures of processed electroencephalography (EEG) signals. These signals are Bispectral Index (BIS), the variability of electromyelogram (sEMG), and the variability of BIS (sBIS). The scale ranges from 0 to 100 where a lower CVI value represents a lower likelihood of intraoperative somatic responses, and a higher CVI value represents a higher likelihood of intraoperative somatic responses.
Measured: Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention
Secondary outcomes (1)
The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups
Mean CVI from incision to propofol off reported as the mean CVI +/- 95% confidence interval for the two groups
Measured: Maintenance Anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionDec 2013
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald M Mathews, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450813
- Sponsor's protocol ID
- COVMOPR0176
- Status last verified
- Apr 2017
- First submitted
- 22 Sep 2011
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data collected was for device algorithm development
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy
- ClinicalTrials.gov ID
- NCT01450813
- Acronym / sponsor ID
- COVMOPR0176
- Conditions
- Anesthesia, Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness. The Composite Variability Index (CVI) is a new index that may provide the anesthesiologist with more information about the condition of the patient. The CVI is a measure of the combined variability in BIS (bispectral index) and frontal electromyography (EMG) activity that may be useful in assessing the nociception/anti-nociception balance for patients under general anesthesia.The purpose of this study is to determine if a commonly used anesthetic drug (rocuronium) affects the CVI measurement differently with different doses. Rocuronium is a neuromuscular blocking agent (NMBA) routinely used during surgery. It is expected that the group given the highest dose of rocuronium will have diminished CVI values.
This study will randomize patients to one of four doses of rocuronium: no rocuronium, 0.2, 0.4, and 0.6 milligrams per kilo of body weight; the last dose is the standard amount for adults. It is expected that the group given the highest dose of rocuronium will have diminished CVI values. By including intermediate doses, information about the function of CVI in states of less than full muscle relaxation, or paralysis, will be obtained. This information is critically important for the development of the composite variability index, because during general anesthesia patients are usually maintained in a state of less than full paralysis. If the CVI response to stimulation in the intermediate groups is similar to the group receiving no rocuronium, the monitor may find wide clinical applicability. If the response is similar to the maximal rocuronium group, the index may only be reliable in states with no muscle relaxant, which will greatly limit clinical utility.
Detailed description
Consented subjects randomized to one of four doses of rocuronium will be transported to the operating room and be connected to routine monitors that included a BIS (Covidien), M-Entropy sensor (GE Healthcare) and TOF (train of four) monitor. Following preoxygenation, general anesthesia will be induced with propofol and remifentanil using traditional syringe pumps. The induction doses given and subsequent infusion rates will be determined by utilizing pharmacokinetic (Pk) models (Marsh model for propofol, Minto model for remifentanil). Unconsciousness will be confirmed by performing the usual clinical assessments and by obtaining a BIS value between 40 and 50. Once the subject is unconsciousness, they will be given the assigned dose of rocuronium, after which the study anesthesiologist will perform a laryngoscopy. The anesthesiologist performing the laryngoscopy will not know what dose of rocuronium the subject received. Neuromuscular blockade (NMB) will be monitored by a train-of-four twitch monitor (TOF Watch-SX) at the adductor pollicis muscle (2 HZ, 50mAmp) every 15 seconds.
At three minutes after the rocuronium administration, a standardized 20-second laryngoscopy will be applied. The CVI, entropy, and hemodynamic responses (heart rate, blood pressure measurement each minute) and train-of-four measurements will be monitored for three minutes before and after the laryngoscopy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Sham comparator | Drug: Saline 0.06 ml/kgSaline 0.06 ml/kg |
| Group 2 | Active comparator | Drug: Rocuronium 0.2 mg/kgRocuronium 0.2 mg/kg |
| Group 3 | Active comparator | Drug: Rocuronium 0.4 mg/kgRocuronium 0.4 mg/kg |
| Group 4 | Active comparator | Drug: Rocuronium 0.6 mg/kgRocuronium 0.6 mg/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesia (ASA) physical status class I or II.
- Body mass index between 18 and 35 kg m-2.
- No use of psychotropic or neuropsychiatric medications.
- A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
- Age between 18-75 years.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
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 |
|---|---|---|
| Saline 0.06 ml/kgAlso: Normal SalineIV Infusion x1 prior to laryngoscopy | Drug | Group 1 |
| Rocuronium 0.2 mg/kgAlso: Rocuronium bromide: ZemuronIV Infusion x1 prior to laryngoscopy | Drug | Group 2 |
| Rocuronium 0.4 mg/kgAlso: Rocuronium bromide: ZemuronIV Infusion x1 prior to laryngoscopy | Drug | Group 3 |
| Rocuronium 0.6 mg/kgAlso: Rocuronium bromide: ZemuronIV Infusion x1 prior to laryngoscopy | Drug | Group 4 |
Primary outcome
The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups
Time frame: Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention
The difference between the mean CVI in three minutes prior to laryngoscopy and three minutes following laryngoscopy reported as the mean change in CVI and the +/- 95% confidence interval for each group. The Composite Variability Index (CVI) scale is a logistic regression of three measures of processed electroencephalography (EEG) signals. These signals are Bispectral Index (BIS), the variability of electromyelogram (sEMG), and the variability of BIS (sBIS). The scale ranges from 0 to 100 where a lower CVI value represents a lower likelihood of intraoperative somatic responses, and a higher CVI value represents a higher likelihood of intraoperative somatic responses.
1 secondary outcome
The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups
Time frame: Maintenance Anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data collected was for device algorithm development
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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.
Donald M Mathews, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg and Rocuronium 0.4 mg/kg in people with Anesthesia and Neuromuscular Blockade, run by Medtronic - MITG at 1 site in United States.
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 5 inclusion and 1 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 12 May 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 United States. 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. Some participants in this study may receive a placebo. 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 12 May 2017). 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?
The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups (time frame: Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.