N/A
Completed N=80
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
Source: ClinicalTrials.gov NCT01450813 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups — 2.40; 1.39; 0.48; 0.17 units on a scale — p=< 0.05
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups |
2.40; 1.39; 0.48; 0.17 | < 0.05 sig |
| SECONDARY The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups |
1.73; 1.38 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Does not meet inclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01450813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.