Neuromuscular Blockade
Conditions
Keywords
neuromuscular blockade; general anesthesia
Brief summary
This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.
Interventions
OTHERNeuromuscular Blocking Agent (NMBA)
While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug\[s\]) are not specified in the protocol.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Informed consent signed * Admission for elective surgery * Administration of nondepolarizing NMBAs during surgery
Exclusion criteria
* Admission for emergency surgery * Reoperation on the same hospital admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival | Upon arrival in the PACU | The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio \<0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | From start of surgery through PACU arrival | Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade. |
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane | From start of surgery through PACU arrival | Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade. |
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents | From end of surgery through PACU arrival, an expected average of 10 minutes | Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade. |
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events | From end of surgery through hospital discharge, an expected average of 6 days | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia
with neuromuscular blocking agents | 350 |
| Total | 350 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 15.9 |
| Sex: Female, Male Female | 216 Participants |
| Sex: Female, Male Male | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 350 |
| serious Total, serious adverse events | 3 / 350 |
Outcome results
Primary
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio \<0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).
Time frame: Upon arrival in the PACU
Population: Full analysis set (FAS) population includes all treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival | 91 participants |
Secondary
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents
Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.
Time frame: From start of surgery through PACU arrival
Population: FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Atracurium | 13 participants |
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Cisatracurium | 35 participants |
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Rocuronium | 31 participants |
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Vecuronium | 8 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Vecuronium | 17 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Atracurium | 42 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Rocuronium | 118 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | Participants Receiving Cisatracurium | 73 participants |
Comparison: Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.p-value: =0.169Chi-square test or Fisher's Exact Test
Secondary
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents
Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.
Time frame: From end of surgery through PACU arrival, an expected average of 10 minutes
Population: FAS population includes all treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents | 71 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents | 162 participants |
Comparison: Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.p-value: =0.01Chi-square test or Fisher's Exact Test
Secondary
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane
Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.
Time frame: From start of surgery through PACU arrival
Population: FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane | Participants Receiving Propofol | 60 participants |
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane | Participants Receiving Sevoflurane | 4 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane | Participants Receiving Propofol | 169 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane | Participants Receiving Sevoflurane | 24 participants |
Secondary
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events
Time frame: From end of surgery through hospital discharge, an expected average of 6 days
Population: FAS population includes all treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events | 12 participants |
| P07535 Study Participants With a TOF Ratio ≥0.9 | Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events | 21 participants |