Neuromuscular Blockade
Conditions
Keywords
surgical conditions, laparoscopy
Brief summary
To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg. Hypothesis: Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.
Interventions
DRUGrocuronium
DRUGsugammadex
DRUGplacebo
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients \> 18 years old * elective laparoscopic operation * can read and understand Danish * informed consent
Exclusion criteria
* BMI \> 30 kg/cm2 * known allergy to medications that are included in the project, * severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis), * neuromuscular disease that may interfere with neuromuscular data, * lactating or pregnant, * impaired liver function, * converting to laparotomy, * perioperative use of neuromuscular blocking agents before randomization, * pneumoperitoneum set to \>12 mmHg on the insufflator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraabdominal Distance (Centimeters) | 1 hour | Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraabdominal Distance (Centimeters) | 1 hour | Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). |
| Surgical Conditions During Suturing of the Abdominal Fascia | 1 hour | Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4) |
Countries
Denmark
Participant flow
Recruitment details
Carried out between November 2013 and April 2014. Center for Minimal Invasive Gynaecology, Aleris-Hamlet Hospital Copenhagen, Denmark. A total of 25 patients were eligible in the study period, of which nine declined to participate, and two were excluded due to the fact that they did not speak Danish. All 14 patients completed the study
Participants by arm
| Arm | Count |
|---|---|
| Patient Characteristics in 14 Women | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Patient Characteristics in 14 Women |
|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 7.7 |
| BMI | 22.2 kg/m2 STANDARD_DEVIATION 2.6 |
| Number of patients with 0 pregnancies | 6 participants |
| Number of patients with 1 pregnancy | 3 participants |
| Number of patients with 2 pregnancies | 2 participants |
| Number of patients with 3 pregnancies | 3 participants |
| Number of patients with previous abdominal surgery | 7 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Intraabdominal Distance (Centimeters)
Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).
Time frame: 1 hour
Population: Comparisons of changes in distances were performed with paired t-test.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Deep Neuromuscular Block | Intraabdominal Distance (Centimeters) | 9.3 centimeters |
| No Neuromuscular Block | Intraabdominal Distance (Centimeters) | 9.0 centimeters |
p-value: <0.0595% CI: [0.07, 0.59]t-test, 2 sided
Secondary
Intraabdominal Distance (Centimeters)
Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).
Time frame: 1 hour
Population: Comparisons of changes in distances were performed with paired t-test
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Deep Neuromuscular Block | Intraabdominal Distance (Centimeters) | 8.6 centimeters |
| No Neuromuscular Block | Intraabdominal Distance (Centimeters) | 8.2 centimeters |
p-value: <0.0595% CI: [0.06, 0.54]t-test, 2 sided
Secondary
Surgical Conditions During Suturing of the Abdominal Fascia
Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)
Time frame: 1 hour
Population: Evaluation of surgical conditions was compared using Mann-Whitney U-test.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deep Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Optimal (score 1) | 7 participants |
| Deep Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Acceptable (score 3) | 0 participants |
| Deep Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Poor (score 4) | 0 participants |
| Deep Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Good (score 2) | 0 participants |
| No Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Poor (score 4) | 0 participants |
| No Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Optimal (score 1) | 2 participants |
| No Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Good (score 2) | 5 participants |
| No Neuromuscular Block | Surgical Conditions During Suturing of the Abdominal Fascia | Acceptable (score 3) | 0 participants |