The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Contact: Donald Mathews, MD | 212-604-7566 | dmathews@svcmcny.org |
| 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 | |
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:
|
Neuromuscular Blocking Agents Rocuronium Remifentanil Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Neuromuscular Nondepolarizing Agents Analgesics, Opioid |
Analgesics Sensory System Agents Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 22, 2013