Phase 4
N=79
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
Cholecystitis · Endometriosis · Bowel Obstruction · Fibroids · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02812186 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Peak Airway Pressures — 25.5; 28.3; 28; 30 cm H2O — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Deep to Moderate NMB (Procedure); Moderate to Deep NMB (Procedure); Rocuronium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Airway Pressures |
25.5; 28.3; 28; 30 | 0.01 sig |
| SECONDARY Abdominal Insufflation Pressure |
15; 15 | 0.28 |
| SECONDARY Surgical Rating Scale |
5; 5 | 0.63 |
Summary
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.
Eligibility Criteria
Inclusion Criteria
- Each participant must be willing and able to provide written informed consent for the study.
- Each participant must be American Society of Anesthesiologists (ASA) class I, II or III.
- Each participant must be scheduled for elective laparoscopic surgery (this includes robotic laparoscopic surgery).
- Expected surgical duration of 60 min or longer
Exclusion Criteria
- Inability to give informed oral or written consent
- Known or suspected neuromuscular disorders impairing neuromuscular function;
- True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle relaxants, anesthetics or opioids
- A history (patient or family) of malignant hyperthermia
- A contraindication for neostigmine administration
- Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal level
- Body mass index >40 kg/m^2
- Significant respiratory disease.
- Planned postoperative mechanical ventilation
Data sourced from ClinicalTrials.gov (NCT02812186). 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.