The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by St. Vincent's Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Covidien
Information provided by:
St. Vincent's Medical Center
ClinicalTrials.gov Identifier:
NCT00926718
First received: June 19, 2009
Last updated: June 22, 2009
Last verified: June 2009
  Purpose

Eighty subjects will be recruited from those scheduled for surgery requiring general anesthesia at St Vincent's Hospital. Subjects must have American Society of Anesthesiologists (ASA) status of 1 or 2 (be fairly healthy), a BMI between 18-35 (reasonably healthy weight), and be between the ages of 18 and 75. They will not be eligible if they take certain medications or are expected to have a difficult intubation.

Subjects will be randomized (assigned by chance) to one of four rocuronium doses of 0, 0.2, 0.4, or 0.6 mg kg-1. All are acceptable clinical doses for performing a laryngoscopy. In the operating room, routine monitors will be applied, including a Bispectral Index (BIS) sensor and an M-Entropy sensor. Subjects will receive 0.025 mg kg-1 midazolam (a standard pre-op dose) and will be put to sleep. Once asleep, the subject will receive a rocuronium dose, followed by laryngoscopy three minutes later. The anesthesiologist performing the laryngoscopy will not know what dose of rocuronium the subject received. CVI, entropy, amount of muscle relaxation, and vital signs will be monitored and recorded throughout the procedure.

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.


Condition Intervention
Laryngoscopy
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 CVI to Laryngoscopy

Resource links provided by NLM:


Further study details as provided by St. Vincent's Medical Center:

Primary Outcome Measures:
  • Variable response to medication given. [ Time Frame: 1-6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Primary Completion Date: June 2010 (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
Experimental: Dose 2a Drug: rocuronium dose + remifentanil infusion
rocuronium dose 0.4 mg/kg+ remifentanil infusion of 2ng ml-1
Experimental: Dose 3a Drug: rocuronium dose + remifentanil infusion
rocuronium dose 0.6 mg/kg+ remifentanil infusion of 2ng ml-1
Experimental: Dose 1b Drug: remifentanil infusion
rocuronium dose 0 mg/kg + remifentanil infusion of 8ng ml-1
Experimental: Dose 2b Drug: rocuronium dose + remifentanil infusion
rocuronium dose 0.4 mg/kg+ remifentanil infusion of 8ng ml-1
Experimental: Dose 3b Drug: rocuronium dose + remifentanil infusion
rocuronium dose 0.6 mg/kg+ remifentanil infusion of 8ng ml-1

  Show Detailed Description

  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 Malampatti 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: NCT00926718

Contacts
Contact: Donald Mathews, MD 212-604-7566 dmathews@svcmcny.org

Locations
United States, New York
Saint Vincent Catholic Medical Centers Recruiting
New York, New York, United States, 10011
Contact: Donald Mathews, MD    212-604-7566    dmathews@svcmcny.org   
Principal Investigator: Donald Mathews, MD         
Sponsors and Collaborators
St. Vincent's Medical Center
Covidien
  More Information

No publications provided

Responsible Party: Donald Mathews, MD, Associate Chair, Anesthesiology, Saint Vincents Catholic Medical Centers
ClinicalTrials.gov Identifier: NCT00926718     History of Changes
Other Study ID Numbers: SVCMC_09_021
Study First Received: June 19, 2009
Last Updated: June 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by St. Vincent's Medical Center:
BIS monitor
rocuronium
The effect of the neuromuscular blocking drug rocuronium on the response of the Composite Variability Index to laryngoscopy

Additional relevant MeSH terms:
Remifentanil
Rocuronium
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Nondepolarizing Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014