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
  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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 2a Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.2 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 3a Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.4 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 4a Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.6 mg/kg + Remifentanil infusion of 2ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 1b Drug: Remifentanil infusion
Rocuronium dose 0 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 2b Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.2 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 3b Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.4 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva
Experimental: Dose 4b Drug: Rocuronium dose + Remifentanil infusion
Rocuronium dose 0.6 mg/kg + Remifentanil infusion of 8ng ml-1
Other Names:
  • Rocuronium bromide: Zemuron
  • Remifentanil: Ultiva

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450813

Contacts
Contact: Jacquelyn Conace 781-690-8607 jacquelyn.conace@covidien.com

Locations
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05405
Principal Investigator: Donald Mathews, MD         
Sponsors and Collaborators
Covidien
  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 July 20, 2014