Gastrointestinal Cancer
Conditions
Brief summary
The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade. The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.
Interventions
DRUGGroup STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).
DRUGGroup DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years old * Elective open upper abdominal surgery * Can read and understand Danish * Informed consent
Exclusion criteria
* Known allergy to rocuronium or sugammadex * Severe renal disease, defined by S-creatinine\> 0.200 mmol/L, GFR \< 30ml/min or hemodialysis * Neuromuscular disease that may interfere with neuromuscular data * Abdominal mesh with size larger than 5\*5 cm * Lactating or pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Rating Score | After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes | The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Surgical Rating Score During Fascial Closure | Immediatly after fascial closure | After last suture of fascial closure surgical conditions are rated on a 5 point scale |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Neuromuscular Blockade Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo). | 63 |
| Deep Neuromuscular Blockade Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment. | 65 |
| Total | 128 |
Baseline characteristics
| Characteristic | Deep Neuromuscular Blockade | Total | Standard Neuromuscular Blockade |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 11 | 64 years STANDARD_DEVIATION 10 | 65 years STANDARD_DEVIATION 10 |
| Body mass index | 26 kg/m^2 STANDARD_DEVIATION 5 | 25 kg/m^2 STANDARD_DEVIATION 5 | 25 kg/m^2 STANDARD_DEVIATION 5 |
| Previous abdominal surgery | 46 Participants | 85 Participants | 39 Participants |
| Sex: Female, Male Female | 27 Participants | 56 Participants | 29 Participants |
| Sex: Female, Male Male | 38 Participants | 72 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 0 / 65 |
| serious Total, serious adverse events | 0 / 63 | 0 / 65 |
Outcome results
Primary
Surgical Rating Score
The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)
Time frame: After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Neuromuscular Blockade | Surgical Rating Score | 4 units on a scale |
| Deep Neuromuscular Blockade | Surgical Rating Score | 4.75 units on a scale |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
The Surgical Rating Score During Fascial Closure
After last suture of fascial closure surgical conditions are rated on a 5 point scale
Time frame: Immediatly after fascial closure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Neuromuscular Blockade | The Surgical Rating Score During Fascial Closure | 4 units on a scale |
| Deep Neuromuscular Blockade | The Surgical Rating Score During Fascial Closure | 5 units on a scale |
p-value: <0.05Wilcoxon (Mann-Whitney)