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NCT01450813 · ClinicalTrials.gov registry record · NA
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
A NA study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT01450813 is a NA study that has completed, run by Medtronic - MITG. The registered enrollment target is 80 participants.
The verdict
NCT01450813, a NA study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study 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.
Interventions
- DRUG Saline 0.06 ml/kg
- DRUG Rocuronium 0.2 mg/kg
- DRUG Rocuronium 0.4 mg/kg
- DRUG Rocuronium 0.6 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01450813
The ClinicalTrials.gov registry entry for NCT01450813 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic - MITG, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Saline 0.06 ml/kg is the first listed.
NCT01450813 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01450813 about?
NCT01450813 is a clinical study titled "The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During 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 pati...
What is the current status of trial NCT01450813?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2009-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01450813?
The interventions under investigation include: Saline 0.06 ml/kg (DRUG), Rocuronium 0.2 mg/kg (DRUG), Rocuronium 0.4 mg/kg (DRUG), Rocuronium 0.6 mg/kg (DRUG).
Who is sponsoring clinical trial NCT01450813?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
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