Neuromuscular Blockade
Conditions
Brief summary
Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition and recovery profile compared with moderate NMB during TURB. This study was designed to compare patients with deep neuromuscular blockade (NMB) with moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical condition and postoperative recovery.
Detailed description
Transurethral resection of the bladder tumor (TURB) is the mainstream treatment of bladder cancer. TURB may be performed under regional anesthesia or general anesthesia. During regional anesthesia for TURB, obturator nerve block should be performed to prevent adductor contraction and possible inadvertent bladder perforation. Additionally, some patients prefer not to be conscious during the surgery and patients with spinal deformity or previous spinal fusion surgery are prone to fail regional anesthesia. Therefore, general anesthesia with neuromuscular blockade (NMB) is frequently conducted for patients with TURB. During general anesthesia for TURB, NMB is needed for intubation and optimal endoscopic surgical condition via obturator nerve block. TURB is a relatively short procedure but patients with NMB usually need sufficient time to be reversed with the conventional NMB reversal agents (anticholinesterases). Additionally, inadequate reversal from NMB may result in respiratory complication during recovery. Sugammadex, a newer reversal agent, is a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced NMB. With the introduction of sugammadex, immediate reversal of deep NMB has become possible without residual NMB. Several previous studies evaluated the effect of NMB on surgical condition for relative short surgeries such as laparoscopic cholecystectomy or laryngeal micro-surgery. They suggested that deep NMB and reversal with sugammadex improved surgical condition without postop respiratory complications. TURB is a urological endoscopic procedure performed in a narrow bladder space but the beneficial effects of deep NMB with sugammadex reversal for TURB have not been thoroughly evaluated. We hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition compared with moderate NMB during TURB. Therefore, this study was designed to compare deep NMB with moderate NMB during TURB in terms of surgical condition and recovery profiles in patients with general anesthesia.
Interventions
DRUGRocuronium
Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.
DRUGSugammadex
Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
Sponsors
MSD Korea Ltd.
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged more than 18 years * American Society of Anesthesiologists (ASA) physical status I and II * scheduled to undergo elective Transurethral resection of the bladder tumor (TURB)
Exclusion criteria
* history of neuromuscular, renal, or hepatic disease * a body mass index (BMI) of \< 18.5 or \> C 30.0 kg/m2 * treatment with drugs known to interfere with neuromuscular function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Attaining a 5 (Optimal) Surgical Condition Score | immediately following the operation, an average of 5 minutes | 5-point surgical condition scale was evaluated as follows. 1. Extremely poor * unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given. 2. Poor * severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed. 3. Acceptable * a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration. 4. Good * a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration. 5. Optimal * a wide endoscopic working field without any movement or contractions. No additional NMB is needed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Residual Curarization | at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes | the number of participant with Postoperative residual curarization (PORC, TOF ratio \< 0.9 ) |
| Recovery Time (PACU Discharge) | During PACU stay (An average of 15 minutes) | time needed to reach a modified Aldrete score of 9 |
| the Incidence of Desaturation | During PACU stay (An average of 15 minutes) | Respiratory complication such as desaturation (SpO2 \< 90%) were recorded during PACU stay. |
| Other Postoperative Adverse Events | During PACU stay (An average of 15 minutes) | Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate Neuromuscular Blockade During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2. | 53 |
| Deep Neuromuscular Blockade During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2. | 51 |
| Total | 104 |
Baseline characteristics
| Characteristic | Moderate Neuromuscular Blockade | Deep Neuromuscular Blockade | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 47 Participants | 95 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 11 | 68 years STANDARD_DEVIATION 10 | 69 years STANDARD_DEVIATION 11 |
| operation time | 23 min STANDARD_DEVIATION 13 | 22 min STANDARD_DEVIATION 13 | 23 min STANDARD_DEVIATION 13 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 53 Participants | 51 Participants | 104 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 46 Participants | 42 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 |
| other Total, other adverse events | 0 / 53 | 0 / 51 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 |
Outcome results
Primary
Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
5-point surgical condition scale was evaluated as follows. 1. Extremely poor * unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given. 2. Poor * severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed. 3. Acceptable * a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration. 4. Good * a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration. 5. Optimal * a wide endoscopic working field without any movement or contractions. No additional NMB is needed.
Time frame: immediately following the operation, an average of 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate Neuromuscular Blockade | Number of Participants Attaining a 5 (Optimal) Surgical Condition Score | 16 Participants |
| Deep Neuromuscular Blockade | Number of Participants Attaining a 5 (Optimal) Surgical Condition Score | 38 Participants |
Secondary
Incidence of Postoperative Residual Curarization
the number of participant with Postoperative residual curarization (PORC, TOF ratio \< 0.9 )
Time frame: at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes
Population: One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate Neuromuscular Blockade | Incidence of Postoperative Residual Curarization | 0 Participants |
| Deep Neuromuscular Blockade | Incidence of Postoperative Residual Curarization | 0 Participants |
Secondary
Other Postoperative Adverse Events
Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort
Time frame: During PACU stay (An average of 15 minutes)
Population: One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate Neuromuscular Blockade | Other Postoperative Adverse Events | 0 Participants |
| Deep Neuromuscular Blockade | Other Postoperative Adverse Events | 0 Participants |
Secondary
Recovery Time (PACU Discharge)
time needed to reach a modified Aldrete score of 9
Time frame: During PACU stay (An average of 15 minutes)
Population: One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Neuromuscular Blockade | Recovery Time (PACU Discharge) | 15 minutes | Standard Deviation 0 |
| Deep Neuromuscular Blockade | Recovery Time (PACU Discharge) | 15 minutes | Standard Deviation 0 |
Secondary
the Incidence of Desaturation
Respiratory complication such as desaturation (SpO2 \< 90%) were recorded during PACU stay.
Time frame: During PACU stay (An average of 15 minutes)
Population: One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate Neuromuscular Blockade | the Incidence of Desaturation | 0 Participants |
| Deep Neuromuscular Blockade | the Incidence of Desaturation | 0 Participants |