Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03958201 |
Other study ID # |
STUDY00007084 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
May 28, 2019 |
Est. completion date |
March 31, 2020 |
Study information
Verified date |
October 2022 |
Source |
University of Washington |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to demonstrate that the investigators can reduce residual
paralysis to a very low incidence, and that the investigators can do this while preserving a
role for the older and less expensive reversal agent neostigmine. The investigators consider
this an evidence-based approach because previous reports clearly indicate that neostigmine is
effective for reversal of the most shallow neuromuscular blocks, a level of block now
referred to as minimal block. The Investigators also know from previous data that a
substantial proportion of patients have minimal block. Sugammadex will be used when the block
to be reversed is deeper than minimal, specifically when the objectively measured TOF-ratio
is <40%.
The investigators hypothesize that this protocol will be associated with an incidence of
residual paralysis of less than 3%. The investigators plan is to study 200 patients.
Description:
This study implements a standardized protocol for NMBD (neuromuscular blocking drug)
management that is currently used by some providers at UWMC and HMC to help prevent residual
paralysis in surgical patients. While this protocol is within the scope of routine care that
an anesthesiologist could follow in his/her clinical practice, it is not consistently used
throughout HMC and UWMC. This protocol follows clinical best practices for NMBD management in
a surgical population and adheres to the recommendations from the P&T committee on reversal
drug choice and recommendations from the Department of Anesthesiology and Pain Medicine on
neostigmine dosing. While this protocol is in line with best practices, the investigators are
continuing to systematically evaluate it in the setting of prospective research. All drugs
will be administered for clinical care only. This research does not add additional
medications. The study will take place at UWMC and HMC and will follow a standardized
research protocol for the timing, dosing, and monitoring surrounding muscle relaxants and
reversal, and makes use of objective TOF monitors. If a patient agrees to participate in this
study, the following research protocol will occur:
Before Surgery:
1. TOF measurements before surgery: A study investigator will perform the routine clinical
train-of-four measurements with an objective monitor at baseline after the clinical
induction of general anesthesia but before the administration of the NMBD. Information
will be recorded for research purposes. Research staff will leave the operating room
after obtaining the baseline measurement and will return to the operating room at the
end of the surgical procedure, to be available for TOF ratio measurements at the time
that reversal of paralysis is planned as well as for the primary outcome measurement,
i.e. at time of extubation.
2. Dose calculation of initial NMBD: A study investigator will assist the anesthesia
provider with calculation of the recommended intubating dose of rocuronium (an NMBD).
The dose will be calculated per this research protocol based on Ideal Body Weight (IBW).
1. For women 45.5 kg plus 2.3 kg/inch over 5 feet of height
2. For men 50 kg plus 2.3 kg/inch over 5 feet of height.
3. For routine intubations, the recommended dose for intubation will be a maximum of
Rocuronium 0.6 mg/kg.
4. The intubating dose will be reduced by 15% for females.
5. Higher intubating dose may be used at the discretion of the anesthesia provider
During Surgery:
1. Additional dose calculation of NMBD: Each additional dose of rocuronium will be 25% of the
recommended intubating dose and will be administered when the TOF count has returned to at
least 2, the aim is to maintain an intraoperative TOF count of 1-2 unless the anesthesia
provider has deemed deep paralysis to be necessary in which case a TOF count of 0 will be
maintained. An attempt will be made to avoid administration of rocuronium during the last 30
minutes of the procedure.
After Surgery:
1. Patients will receive reversal drugs for their routine care that will help reverse the
effects of their muscle relaxant. In this study, the decision of reversal drug use will
follow institutional guidelines. The timing and dose calculation of the reversal drug
will follow the research protocol as follows:
2. Timing of neostigmine or sugammadex: Based on the results of the clinical pre-reversal
TOF assessment, reversal with neostigmine will be administered if the objective
TOF-ratio is between 40%-90%. If the block is deeper than this, then sugammadex will be
used for reversal (This is per institutional guidance on choice of reversal drug).
3. Dose calculation of neostigmine and sugammadex: For this study, the dose of neostigmine
will be calculated based on the IBW. The dose of sugammadex will be calculated based on
patients' actual body weight.
For all subjects enrolled in this study, the investigators will follow a dose schedule
which is based on clinical TOF monitoring and is in accordance with institutional
recommendations for dosing of neostigmine.
4. Timing of extubation: The patient's trachea will not be extubated before routine
objective monitoring confirms recovery to a TOF-ratio 90%. However, in the case that
objective monitoring cannot be obtained by the provider then the following will happen:
1. For subjects who receive neostigmine for their routine care, it is recommended that
the patient's trachea will not be extubated earlier than 10 minutes after the
administration of this drug.
2. For subjects who receive sugammadex for routine care, it is recommended that the
patient's trachea will not be extubated earlier than 3 minutes after drug
administration.
5. TOF measurements after surgery (extubation): The TOF-ratio will be measured by a study
investigator or provider at the time of extubation. Information will be recorded for
research purposes. If the investigators miss obtaining research measurements at the time
of extubation, they will obtain TOF measurements on the patient's arrival to the PACU.
6. Collection of data from EMR: the investigators will collect information from the
patient's medical record including the intraoperative TOF counts, ASA class, surgical
procedure, times of the surgical procedure, time and dose of administered medications,
and the patient's temperature in the operating room and PACU.