NCT03276026

A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery

A Randomized Prospective Study to Compare the Effectiveness of Neostigmine Versus Sugammadex in Length of PACU Stay in ASA II and III Patients Undergoing Sleeve Gastrectomy Bariatric Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Virtua Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The investigators will track bariatric patients who received sugammadex versus neostigmine in the post anesthesia care unit until discharge and assess their length of stay and possible nausea / vomiting / hypoxia episodes.

Detailed description

During their preadmission testing, patients planning to undergo sleeve gastrectomy bariatric surgeries will be consented (by having them sign consent forms) and recruited for the study. A trained individual will track these patients after the surgery in the post anesthesia care unit until discharge and assess their length of stay and possible nausea / vomiting. The exact time the investigators are looking to assess is patient arrival to the post anesthesia care unit until patient ready for discharge when the anesthesiologist writes the anesthesia evaluation. The time the reversal agent is administered during the start of skin closure until patient medically ready to leave the post anesthesia care unit will also be taken into account. Blinded to the treatment group, the trained individual will ask each patient every 15 minutes after arrival to the post anesthesia care unit if they are experiencing nausea or vomiting. As an exploratory measure, the trained individual will assess the patient at these same times (every 15 minutes) and determine their oxygen saturation. The investigators will take all the data from the observations and use statistical means to measure what is significant. A discussion and conclusion will follow. Finally, the principal investigator will submit the study outcomes to an anesthesia journal.

Conditions

• Postoperative Nausea and Vomiting
• Respiratory Conditions Due to Other External Agents

Interventions

Type	Name	Description
DRUG	Sugammadex	Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
DRUG	Neostigmine	Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-11-08
• Completion: 2018-11-08
• First posted: 2017-09-08
• Last updated: 2019-05-28
• Results posted: 2019-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study