Trial Outcomes & Findings for Neuromuscular Blockade During Transurethral Resection of Bladder Cancer (NCT NCT03039543)
NCT ID: NCT03039543
Last Updated: 2018-05-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
immediately following the operation, an average of 5 minutes
Results posted on
2018-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Moderate Neuromuscular Blockade
n=53 Participants
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.
|
Deep Neuromuscular Blockade
n=51 Participants
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.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=53 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=104 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=53 Participants
|
4 Participants
n=51 Participants
|
9 Participants
n=104 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=53 Participants
|
47 Participants
n=51 Participants
|
95 Participants
n=104 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 11 • n=53 Participants
|
68 years
STANDARD_DEVIATION 10 • n=51 Participants
|
69 years
STANDARD_DEVIATION 11 • n=104 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=53 Participants
|
9 Participants
n=51 Participants
|
16 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=53 Participants
|
42 Participants
n=51 Participants
|
88 Participants
n=104 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
53 Participants
n=53 Participants
|
51 Participants
n=51 Participants
|
104 Participants
n=104 Participants
|
|
operation time
|
23 min
STANDARD_DEVIATION 13 • n=53 Participants
|
22 min
STANDARD_DEVIATION 13 • n=51 Participants
|
23 min
STANDARD_DEVIATION 13 • n=104 Participants
|
PRIMARY outcome
Timeframe: immediately following the operation, an average of 5 minutes5-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.
Outcome measures
| Measure |
Moderate Neuromuscular Blockade
n=53 Participants
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.
|
Deep Neuromuscular Blockade
n=51 Participants
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.
|
|---|---|---|
|
Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
|
16 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutesPopulation: 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)
the number of participant with Postoperative residual curarization (PORC, TOF ratio \< 0.9 )
Outcome measures
| Measure |
Moderate Neuromuscular Blockade
n=53 Participants
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.
|
Deep Neuromuscular Blockade
n=51 Participants
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.
|
|---|---|---|
|
Incidence of Postoperative Residual Curarization
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)
time needed to reach a modified Aldrete score of 9
Outcome measures
| Measure |
Moderate Neuromuscular Blockade
n=53 Participants
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.
|
Deep Neuromuscular Blockade
n=51 Participants
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.
|
|---|---|---|
|
Recovery Time (PACU Discharge)
|
15 minutes
Standard Deviation 0
|
15 minutes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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)
Respiratory complication such as desaturation (SpO2 \< 90%) were recorded during PACU stay.
Outcome measures
| Measure |
Moderate Neuromuscular Blockade
n=53 Participants
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.
|
Deep Neuromuscular Blockade
n=51 Participants
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.
|
|---|---|---|
|
the Incidence of Desaturation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)
Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort
Outcome measures
| Measure |
Moderate Neuromuscular Blockade
n=53 Participants
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.
|
Deep Neuromuscular Blockade
n=51 Participants
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.
|
|---|---|---|
|
Other Postoperative Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Moderate Neuromuscular Blockade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep Neuromuscular Blockade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Junghee Ryu, Associate Professor
Seoul National University Bundang Hospital
Phone: 82-31-787-7497
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place