Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

• Status: Completed
• Trial end date: 2019-02-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Rocuronium

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