Muscle Weakness
Conditions
Keywords
neostigmine, sugammadex, rocuronium, neuromuscular blocking agents
Brief summary
This is an estimation study, prospectively evaluating the incidence of postoperative residual neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of abdominal surgery and orthopedic surgery patients. The protocol is developed within the constraint of subjective monitoring, quantitative monitoring is not used, and use of rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a train-of-four ration \<0.9.
Detailed description
This study estimates the incidence of postoperative residual neuromuscular block when rocuronium neuromuscular block is managed by protocol for qualitative monitoring and reversal with neostigmine or sugammadex. The study is an extension of the recently published study by Thilen and co-workers which evaluated a protocol which used neostigmine as the sole reversal agent (doi: 10.1016/j.bja.2018.03.029). It demonstrated that use of a protocol was associated with a reduced incidence of severe residual paralysis, defined as normalized train-of-four (TOF) ratio \<0.7 at time of tracheal extubation. It was also associated with a highly significant reduction in PRNB as defined for several secondary outcomes, including non-normalized (i.e. raw) TOF-ratio \<0.9 at time of arrival to the post-anesthesia care unit (PACU). The current study does not include a control group, only an intervention group. The investigators hypothesize that PRNB can be prevented by adhering to a protocol which incorporates several current recommendations by experts. Importantly, the protocol preserves a role for neostigmine when the pre-reversal assessment indicates that spontaneous recovery has progressed to a so-called minimal block which is defined as the subjective absence of fade in the adductor pollicis TOF response. The investigators will study only abdominal surgery and orthopedic surgery patients. The primary outcome is incidence of PRNB, defined as TOF-ratio \<0.9 on arrival to the PACU. The investigators plan to enroll 120 patients, and if no more than one patient has PRNB, the upper bound for the 95% confidence interval will be less than 5%.
Interventions
COMBINATION_PRODUCTProtocol for rocuronium neuromuscular block
The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult 18 years old or older, Will undergo open or laparoscopic abdominal surgery or orthopedic surgery expected to last \<6 hours at Harborview or Univ of Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking drug for endotracheal intubation or intraoperative neuromuscular blockade. \-
Exclusion criteria
Allergy to neuromuscular blocking drugs, patients with neuromuscular disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English speaking. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit. | Within five minutes of arrival to the post-anesthesia care unit. | Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit. | Within five minutes of arrival to the post-anesthesia care unit. | Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography. |
| Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation. | Within two minutes of time of extubation. | Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography. |
| Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation | Within two minutes of time of extubation. | Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography. |
Countries
United States
Participant flow
Pre-assignment details
201 subjects were consented to the study. However, 163 subjects completed the study and were included in the primary per-protocol analysis.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Undergoing Orthopedic or Abdominal Surgery Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation. | 163 |
| Total | 163 |
Baseline characteristics
| Characteristic | Subjects Undergoing Orthopedic or Abdominal Surgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 129 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 135 Participants |
| Region of Enrollment United States | 163 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 163 |
| other Total, other adverse events | 0 / 163 |
| serious Total, serious adverse events | 0 / 163 |
Outcome results
Primary
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.
Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.
Time frame: Within five minutes of arrival to the post-anesthesia care unit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Undergoing Orthopedic or Abdominal Surgery | Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit. | 5 Participants |
Secondary
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation.
Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.
Time frame: Within two minutes of time of extubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Undergoing Orthopedic or Abdominal Surgery | Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation. | 14 Participants |
Secondary
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.
Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography.
Time frame: Within five minutes of arrival to the post-anesthesia care unit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Undergoing Orthopedic or Abdominal Surgery | Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit. | 2 Participants |
Secondary
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation
Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography.
Time frame: Within two minutes of time of extubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Undergoing Orthopedic or Abdominal Surgery | Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation | 1 Participants |