Robot-Assisted Laparoscopic Radical Prostatectomy
Conditions
Keywords
deep neuromuscular blockade, intraocular pressure
Brief summary
Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.
Interventions
PROCEDUREdeep neuromuscular blockade
deep neuromuscular blockade using rocuronium and reverse with sugammadex
PROCEDUREmoderate neuromuscular blockade
moderate neuromuscular blockade using atracurium and reverse with neostigmine
DRUGRocuronium
DRUGSugammadex
DRUGAtracurium
DRUGNeostigmine
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. ASA class I-II 2. obtaining written informed consent from the parents 3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy
Exclusion criteria
1. eye surgery previously 2. unstable angina or congestive heart failure 3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment) 4. high intraocular pressure over 30mmHg after screening test. 5. uncontrolled hypertension (diastolic bp\>110mmHg) 6. coagulopathy 7. asthma 8. hepatic failure 9. renal failure(creatinine clearance \< 30 ml/min) 10. drug hyperactivity 11. neurological or psychiatric illnesses 12. mental retardation 13. patients who can't read the consent form due to illiterate or foreigner 14. previous malignant hyperthermia Hx 15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc) 16. BMI \> 30kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade | Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position | maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Surgical Condition | At the end of the Steep trendelenburg position, an average of 1 hour | overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary. |
Other
| Measure | Time frame |
|---|---|
| Post-operative Nausea | During 24hours after operation |
| Incidence of Residual Neuromuscular Blockade | During 24hours after operation |
Countries
South Korea
Participant flow
Recruitment details
Subjects were screened and enrolled at 1 site in the Korea
Pre-assignment details
No test entered
Participants by arm
| Arm | Count |
|---|---|
| Moderate Neuromuscular Blockade moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine
Atracurium
Neostigmine | 32 |
| Deep Neuromuscular Blockade deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex
Rocuronium
Sugammadex | 34 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Deep Neuromuscular Blockade | Total | Moderate Neuromuscular Blockade |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 28 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 38 Participants | 16 Participants |
| Age, Continuous | 61.5 years STANDARD_DEVIATION 5.4 | 62.7 years STANDARD_DEVIATION 5.7 | 63.9 years STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 34 Participants | 66 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Korea, Republic of | 34 participants | 66 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 34 Participants | 66 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
Time frame: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Neuromuscular Blockade (Moderate NMB Group) | Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade | 23.3 mmHg | Standard Deviation 2.7 |
| Deep Neuromuscular Blockade (Deep NMB Group) | Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade | 19.8 mmHg | Standard Deviation 2.1 |
Secondary
Overall Surgical Condition
overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.
Time frame: At the end of the Steep trendelenburg position, an average of 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Moderate Neuromuscular Blockade (Moderate NMB Group) | Overall Surgical Condition | 4.0 units on a scale |
| Deep Neuromuscular Blockade (Deep NMB Group) | Overall Surgical Condition | 3.0 units on a scale |
Other Pre-specified
Incidence of Residual Neuromuscular Blockade
Time frame: During 24hours after operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moderate Neuromuscular Blockade (Moderate NMB Group) | Incidence of Residual Neuromuscular Blockade | 0 participants |
| Deep Neuromuscular Blockade (Deep NMB Group) | Incidence of Residual Neuromuscular Blockade | 0 participants |
Other Pre-specified
Post-operative Nausea
Time frame: During 24hours after operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moderate Neuromuscular Blockade (Moderate NMB Group) | Post-operative Nausea | 4 events |
| Deep Neuromuscular Blockade (Deep NMB Group) | Post-operative Nausea | 1 events |