The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy

NCT01450813 | Completed Results DMC

• 1 other identifier: COVMOPR0176
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Maintenance Anesthesia

Study Arms (4)

Group 1

SHAM COMPARATOR

Saline 0.06 ml/kg

Drug: Saline 0.06 ml/kg

Group 2

ACTIVE COMPARATOR

Rocuronium 0.2 mg/kg

Drug: Rocuronium 0.2 mg/kg

Group 3

ACTIVE COMPARATOR

Rocuronium 0.4 mg/kg

Drug: Rocuronium 0.4 mg/kg

Group 4

ACTIVE COMPARATOR

Rocuronium 0.6 mg/kg

Drug: Rocuronium 0.6 mg/kg

Interventions

Saline 0.06 ml/kg DRUG

IV Infusion x1 prior to laryngoscopy

Also known as: Normal Saline

Group 1

Rocuronium 0.2 mg/kg DRUG

IV Infusion x1 prior to laryngoscopy

Also known as: Rocuronium bromide: Zemuron

Group 2

Rocuronium 0.4 mg/kg DRUG

IV Infusion x1 prior to laryngoscopy

Also known as: Rocuronium bromide: Zemuron

Group 3

Rocuronium 0.6 mg/kg DRUG

IV Infusion x1 prior to laryngoscopy

Also known as: Rocuronium bromide: Zemuron

Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Saline Solution; Rocuronium

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Sample size for this study calculation was based upon the assumption that that the expected mean of CVI would be 60 with a variance of 30 and that the variance of 30 would be equal for each group.

Results Point of Contact

• Title: Donald Mathews, M.D.
• Organization: Fletcher Allen Health Care at The University of Vermont

Donald.Mathews@vtmednet.org

(802) 847-2415

Study Officials

• Donald M Mathews, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: October 12, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)