Trial Outcomes & Findings for The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy (NCT NCT02109133)
NCT ID: NCT02109133
Last Updated: 2015-06-24
Results Overview
maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position
Results posted on
2015-06-24
Participant Flow
Subjects were screened and enrolled at 1 site in the Korea
No test entered
Participant milestones
| Measure |
Moderate Neuromuscular Blockade (Moderate NMB Group)
Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
|
Deep Neuromuscular Blockade (Deep NMB Group)
Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Moderate Neuromuscular Blockade (Moderate NMB Group)
Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
|
Deep Neuromuscular Blockade (Deep NMB Group)
Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Moderate Neuromuscular Blockade
n=32 Participants
moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine
Atracurium
Neostigmine
|
Deep Neuromuscular Blockade
n=34 Participants
deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex
Rocuronium
Sugammadex
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST positionmaximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
Outcome measures
| Measure |
Moderate Neuromuscular Blockade (Moderate NMB Group)
n=32 Participants
Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
|
Deep Neuromuscular Blockade (Deep NMB Group)
n=34 Participants
Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
|
|---|---|---|
|
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
|
23.3 mmHg
Standard Deviation 2.7
|
19.8 mmHg
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: At the end of the Steep trendelenburg position, an average of 1 houroverall 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.
Outcome measures
| Measure |
Moderate Neuromuscular Blockade (Moderate NMB Group)
n=32 Participants
Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
|
Deep Neuromuscular Blockade (Deep NMB Group)
n=34 Participants
Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
|
|---|---|---|
|
Overall Surgical Condition
|
4.0 units on a scale
Interval 3.0 to 5.0
|
3.0 units on a scale
Interval 2.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 24hours after operationOutcome measures
| Measure |
Moderate Neuromuscular Blockade (Moderate NMB Group)
n=32 Participants
Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
|
Deep Neuromuscular Blockade (Deep NMB Group)
n=34 Participants
Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
|
|---|---|---|
|
Post-operative Nausea
|
4 events
|
1 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 24hours after operationOutcome measures
| Measure |
Moderate Neuromuscular Blockade (Moderate NMB Group)
n=32 Participants
Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
|
Deep Neuromuscular Blockade (Deep NMB Group)
n=34 Participants
Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
|
|---|---|---|
|
Incidence of Residual Neuromuscular Blockade
|
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. Sun-Jun, Bae
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,Severance Hospital, Yonsei University Health System
Phone: +82-02-2228-4438
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place