CompletedPhase 4

Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

United States79 participantsStarted 2016-12-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Peak Airway Pressures

Timeframe: Intra-operative, from intubation time to extubation time

Trial details

NCT IDNCT02812186

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-17

Results submitted2020-02-06