Trial Outcomes & Findings for Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade (NCT NCT02247466)
NCT ID: NCT02247466
Last Updated: 2019-07-02
Results Overview
Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg. (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
3 hours
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Overall Study
Procedure changed to open surgery
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 17 • n=19 Participants
|
55 years
STANDARD_DEVIATION 15 • n=15 Participants
|
56.4 years
STANDARD_DEVIATION 15.5 • n=34 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=19 Participants
|
5 Participants
n=15 Participants
|
9 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=19 Participants
|
10 Participants
n=15 Participants
|
25 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
28 kg/m2
STANDARD_DEVIATION 4 • n=19 Participants
|
30 kg/m2
STANDARD_DEVIATION 4 • n=15 Participants
|
29 kg/m2
STANDARD_DEVIATION 4.17 • n=34 Participants
|
|
ASA 1/2/3
ASA 1
|
5 Participants
n=19 Participants
|
4 Participants
n=15 Participants
|
9 Participants
n=34 Participants
|
|
ASA 1/2/3
ASA 2
|
12 Participants
n=19 Participants
|
10 Participants
n=15 Participants
|
22 Participants
n=34 Participants
|
|
ASA 1/2/3
ASA 3
|
2 Participants
n=19 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=34 Participants
|
|
Previous abdominal surgery
|
12 Participants
n=19 Participants
|
10 Participants
n=15 Participants
|
22 Participants
n=34 Participants
|
|
Herniea size (cm)
|
2.4 cm
STANDARD_DEVIATION 1.5 • n=19 Participants
|
3.1 cm
STANDARD_DEVIATION 2.1 • n=15 Participants
|
2.72 cm
STANDARD_DEVIATION 1.82 • n=34 Participants
|
PRIMARY outcome
Timeframe: 3 hoursImprovement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg. (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Improvement of Surgical Workspace
Changes in ratings 5 to 3
|
0 Participants
|
1 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 4 to 3
|
0 Participants
|
0 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 5 to 4
|
0 Participants
|
4 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 3 to 3
|
1 Participants
|
0 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 4 to 4
|
1 Participants
|
2 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 5 to 5
|
14 Participants
|
4 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 4 to 5
|
2 Participants
|
2 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 3 to 4
|
0 Participants
|
1 Participants
|
|
Improvement of Surgical Workspace
Changes in ratings 3 to 5
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 hoursSurgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale) (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=13 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Surgical Conditions While Suturing
1. Extremely poor conditions
|
0 Participants
|
0 Participants
|
|
Surgical Conditions While Suturing
2. Poor conditions
|
0 Participants
|
0 Participants
|
|
Surgical Conditions While Suturing
3. Acceptable conditions
|
0 Participants
|
2 Participants
|
|
Surgical Conditions While Suturing
4. Good conditions
|
3 Participants
|
4 Participants
|
|
Surgical Conditions While Suturing
5. Optimal conditions
|
16 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 hoursDuration of operating time (from first incision to last suture)
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Operating Time
|
61 minutes
Interval 37.0 to 85.0
|
64 minutes
Interval 33.0 to 95.0
|
SECONDARY outcome
Timeframe: 3 hoursDuration of suturing the hernia (minutes)
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Suturing Time
|
10 minutes
Interval 1.0 to 19.0
|
9 minutes
Interval 2.0 to 16.0
|
SECONDARY outcome
Timeframe: 3 hoursSudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Contractions
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 hoursInsufflator alarms where pneumoperitoneum \> 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum \> 17 mmHg
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Insufflator Alarms
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 hoursNumber of patients experiencing episodes with continuous abdominal contractions where the abdomen feels "tight" but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)
Outcome measures
| Measure |
Group A - Saline, Assesment, Rocuronium and Assesment
n=19 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
Rocuronium and Sugammadex
|
Group B - Rocuronium, Assesment, Sugammadex and Assesment
n=15 Participants
Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
Rocuronium and Sugammadex
|
|---|---|---|
|
Continuous Abdominal Contractions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of recurrences of hernias by 2 year follow-up (separate publication).
Outcome measures
Outcome data not reported
Adverse Events
Group A - Saline, Assesment, Rocuronium and Assesment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B - Rocuronium, Assesment, Sugammadex and Assesment
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
Roar Borregaard Medici, MD, Research Assistant
Department of Anaesthesiology, Herlev Hospital, University of Copenhagen
Phone: +4526390068
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place