Chronic Obstructive Pulmonary Disease, Neuromuscular Blockade
Conditions
Keywords
Nondepolarizing neuromuscular blockade, sugammadex, bronchoscopy, outpatient, lung disease
Brief summary
A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite.
Detailed description
This research study will have the design of a blinded randomized clinical trial. The pharmacist will be blinded to the study medication given. The anesthesia provider cannot be blinded because he/she will need to determine the proper dose and timing of the neuromuscular blocker reversal medication (the study medications) given at the end of the procedure. The study will recruit 80 patients coming to Temple University Hospital for an outpatient bronchoscopy biopsy procedure that requires general anesthesia with neuromuscular blockade. Rocuronium will be the neuromuscular blockade medication given in this study. Inclusion criteria for these patients will include those age \>18 who have a diagnosis of chronic obstructive pulmonary disease (COPD) and/or idiopathic lung disease (ILD) and who require medical treatment for the same; these patients will have American society of anesthesiology physical status (ASA PS) 3-4 based on their pulmonary disease alone.The patients will then be randomly assigned to one of two study arms (40 per arm). Patients in one arm of the study will receive Sugammadex and patients in the other arm will receive neostigmine/glycopyrrolate for reversal of neuromuscular blockade. Due to the nature of bronchoscopy for biopsy, the depth of anesthesia at the end of the case will be difficult to predict; the length of the cases may vary some (although most will be approximately one hour), and patients' metabolism of neuromuscular blocking agents is very much dependent on their personal medication regimens and liver function. Each patient's depth of neuromuscular blockade will be followed using the TwitchView monitor, a commercially available, an electromyography (EMG) based monitor. The TwitchView measures muscle response to delivered electrical stimuli (2Hz) which are sent in sets of 4X0.5 seconds apart (most commonly). The muscles controlled by the ulnar nerve will be followed during this study. Return of muscle strength after reversal agents are given is considered complete when the ratio of the strength of the response to the fourth electrical stimulus to the first stimulus is 0.9. Multiple time points will be recorded, including train of four measurement (TOF) every 5 minutes during the procedure, time and TOF at the end of the procedure, time of reversal medication dosing, time of TOF\>0.9 and time of extubation. Reversal medication will be given as soon as each patient's procedure is complete and the patient meets appropriate criteria for reversal for each respective medication. Comparison of the data from the two arms of the study will then be made.
Interventions
neuromuscular blockade reversal agents
neuromuscular blockade reversal agent
Sponsors
Study design
Masking description
Medications will be provided by Merck, Sharp & Dohme Corp and will be delivered to the inpatient pharmacy in such a way as to blind the pharmacist. Patients will also not know which medication they are receiving
Intervention model description
Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication
Eligibility
Inclusion criteria
1. has diagnosis of COPD or ILD 2. ASA 3 or 4 3. procedure requires general anesthesia in the outpatient bronchoscopy suite 4. glomerular filtration rate \> 30 ml/min
Exclusion criteria
1. pregnant women 2. prisoners 3. those unable to consent for themselves 4. procedures not requiring general anesthesia 5. ASA 1 or 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Minutes to Return of Baseline Muscle Tone | 1-20 minutes | number of minutes from reversal dose to Train of Four (TOF) \>0.9 indicating full reversal of neuromuscular blockade agent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Minutes to Extubation | 1-30 minutes | number of minutes from Train of Four (TOF) \>0.9 to extubation of the patient |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugammadex Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.
sugammadex: neuromuscular blockade reversal agent | 28 |
| Neostigmine/Glycopyrrolate Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade
neostigmine/glycopyrrolate: neuromuscular blockade reversal agents | 30 |
| Total | 58 |
Baseline characteristics
| Characteristic | Neostigmine/Glycopyrrolate | Total | Sugammadex |
|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 8.8 | 65.8 years STANDARD_DEVIATION 8.7 | 66.6 years STANDARD_DEVIATION 8.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 34 Participants | 15 Participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 23 Participants | 41 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 30 |
| other Total, other adverse events | 0 / 28 | 0 / 30 |
| serious Total, serious adverse events | 0 / 28 | 0 / 30 |
Outcome results
Number of Minutes to Return of Baseline Muscle Tone
number of minutes from reversal dose to Train of Four (TOF) \>0.9 indicating full reversal of neuromuscular blockade agent
Time frame: 1-20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Number of Minutes to Return of Baseline Muscle Tone | 3.9 minutes | Standard Deviation 2 |
| Neostigmine/Glycopyrrolate | Number of Minutes to Return of Baseline Muscle Tone | 12.9 minutes | Standard Deviation 9.8 |
Number of Minutes to Extubation
number of minutes from Train of Four (TOF) \>0.9 to extubation of the patient
Time frame: 1-30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Number of Minutes to Extubation | 11.9 minutes | Standard Deviation 8.3 |
| Neostigmine/Glycopyrrolate | Number of Minutes to Extubation | 17.7 minutes | Standard Deviation 10.5 |