N/A
N=100
Effectiveness of Deep Versus Moderate Neuromuscular Blockade
Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT03266419 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU) — 8.0; 8.0 mg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep NMB using rocuronium (Drug); Moderate NMB using rocuronium (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU) |
8.0; 8.0 | — |
| SECONDARY Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU) |
6.1; 6.1 | — |
Summary
The aim of this study is to evaluate the influence of depth of neuromuscular blockade during laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum of 13 mmHg.
Eligibility Criteria
Inclusion Criteria
- Patients 20 to 65 years old
- American Society of Anesthesiologist Physical Status 1, 2 or 3
- Patients undergoing laparoscopic gastrectomy
- Patients who signed a written informed consent form
Exclusion Criteria
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- Patients with known hypersensitivity to rocuronium or sugammadex
- Patient with VAS score (0=no pain; 100=the most severe pain) of at least 10 before surgery
- Patients with liver cirrhosis confirmed by abdominal CT
- Patients with neuromuscular disease that may interfere with neuromuscular data (ex. Duchenne muscular dystrophy, myasthenia gravis)
- Clinically significant impairment of cardiovascular function, defined by ejection fraction 100 IU/L
- Indication for rapid sequence induction
- Use of opioids within the 7 days prior to surgery
- History of abdominal surgery
- History of chronic obstructive pulmonary disease
- Body mass index (BMI) ≥ 35 kg/m2
- Body weight < 50 kg
- Conversion to laparotomy
- Family history of malignant hyperthermia
- Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria
Data sourced from ClinicalTrials.gov (NCT03266419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.