Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

• Status: Withdrawn
• Trial end date: 2020-07-20
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.

The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

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

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Neostigmine

Criteria

Inclusion Criteria:

• ASA physical score II and III

• Scheduled for a laparoscopic ambulatory surgery

• 21-60 years of age

• Able to understand and sign informed consent

Exclusion Criteria:

• Known allergy to neostigmine or sugammadex

• Active pulmonary diagnosis

• American Society of Anesthesia physical score 4 and above

• Known or suspected neuromuscular disease

• Documented renal or liver insufficiency (2 fold increase in the labs)

• Body Mass Index >40

• Any surgical case brought into the operating room after 4 PM (to avoid any provider bias related to discharging patients before closure of the ambulatory surgery center for the day)