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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01450813
First received: September 22, 2011
Last updated: June 5, 2013
Last verified: June 2013

September 22, 2011
June 5, 2013
September 2011
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01450813 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Anesthesia
  • Neuromuscular Blockade
  • Drug: Remifentanil infusion
    Rocuronium dose 0 mg/kg + Remifentanil infusion of 2ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Rocuronium dose + Remifentanil infusion
    Rocuronium dose 0.2 mg/kg + Remifentanil infusion of 2ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Rocuronium dose + Remifentanil infusion
    Rocuronium dose 0.4 mg/kg + Remifentanil infusion of 2ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Rocuronium dose + Remifentanil infusion
    Rocuronium dose 0.6 mg/kg + Remifentanil infusion of 2ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Remifentanil infusion
    Rocuronium dose 0 mg/kg + Remifentanil infusion of 8ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Rocuronium dose + Remifentanil infusion
    Rocuronium dose 0.2 mg/kg + Remifentanil infusion of 8ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Rocuronium dose + Remifentanil infusion
    Rocuronium dose 0.4 mg/kg + Remifentanil infusion of 8ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Drug: Rocuronium dose + Remifentanil infusion
    Rocuronium dose 0.6 mg/kg + Remifentanil infusion of 8ng ml-1
    Other Names:
    • Rocuronium bromide: Zemuron
    • Remifentanil: Ultiva
  • Experimental: Dose 1a
    Intervention: Drug: Remifentanil infusion
  • Experimental: Dose 2a
    Intervention: Drug: Rocuronium dose + Remifentanil infusion
  • Experimental: Dose 3a
    Intervention: Drug: Rocuronium dose + Remifentanil infusion
  • Experimental: Dose 4a
    Intervention: Drug: Rocuronium dose + Remifentanil infusion
  • Experimental: Dose 1b
    Intervention: Drug: Remifentanil infusion
  • Experimental: Dose 2b
    Intervention: Drug: Rocuronium dose + Remifentanil infusion
  • Experimental: Dose 3b
    Intervention: Drug: Rocuronium dose + Remifentanil infusion
  • Experimental: Dose 4b
    Intervention: Drug: Rocuronium dose + Remifentanil infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Jacquelyn Conace 781-690-8607 jacquelyn.conace@covidien.com
United States
 
NCT01450813
COVMOPR0176
Yes
Covidien
Covidien
Not Provided
Not Provided
Covidien
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP