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

NCT00926718 | Unknown

• 1 other identifier: SVCMC_09_021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngoscopy

Keywords

BIS monitor; rocuronium; The effect of the neuromuscular blocking drug rocuronium on the response of the Composite Variability Index to laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Variable response to medication given.

  1-6 hours

Study Arms (6)

Dose 1a

EXPERIMENTAL

Drug: remifentanil infusion

Dose 2a

EXPERIMENTAL

Drug: rocuronium dose + remifentanil infusion

Dose 3a

EXPERIMENTAL

Drug: rocuronium dose + remifentanil infusion

Dose 1b

EXPERIMENTAL

Drug: remifentanil infusion

Dose 2b

EXPERIMENTAL

Drug: rocuronium dose + remifentanil infusion

Dose 3b

EXPERIMENTAL

Drug: rocuronium dose + remifentanil infusion

Interventions

remifentanil infusion DRUG

rocuronium dose 0 mg/kg + remifentanil infusion of 2ng ml-1

Dose 1a

rocuronium dose + remifentanil infusion DRUG

rocuronium dose 0.4 mg/kg+ remifentanil infusion of 2ng ml-1

Dose 2a

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• St. Vincent's Medical Center: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Saint Vincent Catholic Medical Centers

New York, New York, 10011, United States

RECRUITING

Central Study Contacts

Donald Mathews, MD

CONTACT

212-604-7566; dmathews@svcmcny.org

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: UNKNOWN

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

US (1)