The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
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Purpose
The Bispectral Index monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness. The Composite Variability Index, or Composite Variability Index (CVI), is a new index that may provide the anesthesiologist with more information about the condition of the patient. 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 muscle relaxant routinely used during surgery. It is expected that the group given the highest dose of rocuronium will have diminished CVI values.
| Condition | Intervention |
|---|---|
|
Anesthesia Neuromuscular Blockade |
Drug: Remifentanil infusion Drug: Rocuronium dose + Remifentanil infusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy |
- The difference between the mean CVI value prior to laryngoscopy to the maximal CVI reading following laryngoscopy. [ Time Frame: The mean CVI value in the three minutes prior to laryngoscopy will be compared to the maximal CVI reading during the three minutes following laryngoscopy. ] [ Designated as safety issue: No ]
- The average CVI level during the maintenance phase of surgery. [ Time Frame: The maintenance phase is defined as the time from surgical incision to the time that the propofol is turned off. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose 1a |
Drug: Remifentanil infusion
Rocuronium dose 0 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
|
| Experimental: Dose 2a |
Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.2 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
|
| Experimental: Dose 3a |
Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.4 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
|
| Experimental: Dose 4a |
Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.6 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
|
| Experimental: Dose 1b |
Drug: Remifentanil infusion
Rocuronium dose 0 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
|
| Experimental: Dose 2b |
Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.2 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
|
| Experimental: Dose 3b |
Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.4 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
|
| Experimental: Dose 4b |
Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.6 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
|
Detailed Description:
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.
Subjects will receive propofol and remifentanil infusions during the case. These are commonly used medications for anesthesia. The subjects will also be randomized to two additional groups. One group will receive a remifentanil infusion of 2ng ml-1 and the other group will receive a 8ng ml-1 remifentanil infusion. Both doses are acceptable and often used during standard clinical care. The propofol infusion will be adjusted to keep the BIS number between 45-60. The anesthesiologist will not be able to see the CVI value. The times of certain intraoperative events, such as intubation and incision, will be recorded. All subjects will receive a morphine bolus (0.10-0.15 mg/kg) towards the end to reduce post-operative pain, as per standard clinical care. As the subject wakes up, time to eye opening and orientation will be recorded. The subject will rate their pain on a numerical pain scale and the quality of emergence will be assessed.
Upon arrival in the post anesthesia care unit (PACU), subjects will be asked to rate their pain again using the same pain scale. The pain score will be evaluated every 10 minutes for half an hour, then every hour until they are discharged from PACU.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Presence of ASA physical status class I or II. (This will exclude subjects with significant medical problems).
- 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.
Exclusion Criteria:
- Does not meet inclusion criteria.
Contacts and Locations| Contact: Jacquelyn Conace | 781-690-8607 | jacquelyn.conace@covidien.com |
| United States, Vermont | |
| Fletcher Allen Health Care | Recruiting |
| Burlington, Vermont, United States, 05405 | |
| Principal Investigator: Donald Mathews, MD | |
More Information
No publications provided
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT01450813 History of Changes |
| Other Study ID Numbers: | COVMOPR0176 |
| Study First Received: | September 22, 2011 |
| Last Updated: | June 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bromides Remifentanil Rocuronium Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Analgesics, Opioid Analgesics Sensory System Agents Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on June 18, 2013