At a glance
ClinicalIndex Comparison Record- ✓ASA class I, II, or III
- ✓Scheduled for elective laparoscopic surgery (including robotic laparoscopic)
- ✓Expected surgical duration of 60 minutes or longer
- ✓Willing and able to provide written informed consent
- ✕Known or suspected neuromuscular disorders impairing neuromuscular function
- ✕True allergies (hypotension, bronchospasm, or anaphylaxis) to muscle relaxants, anesthetics, or opioids
- ✕History (patient or family) of malignant hyperthermia
- ✕Contraindication for neostigmine administration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery
In Brief
A Phase 4 clinical trial evaluating Deep to Moderate NMB, Moderate to Deep NMB, and 1 other intervention for Cholecystitis and 6 related conditions. Completed, enrolled 79 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a "moderate" NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade.
Rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 ("deep" NMB) the infusion will be adjusted to maintain the patient at this level of NMB.