Clinical trial NCT03276026: A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Respiratory Conditions Due to Other External Agents
Keywords: sugammadex
post anesthesia care unit recovery
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-09-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients having sleeve gastrectomy
* Surgeries performed by a particular surgeon - Dr. Sam Wasser
* Body Mass Index greater than 35
* American Society of Anesthesiologists Score II and III patients

Exclusion Criteria:

* Patients having a different type of bariatric surgery including but not limited to duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy
* Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser.
* Pregnancy
* Allergic to sugammadex, Zofran or scopolamine
* Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled
* American Society of Anesthesiologists Score I, IV, V patients

Primary outcomes:
measure: Post Anesthesia Care Unit Length of Stay
timeFrame: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
Secondary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting
timeFrame: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
measure: Incidence of Respiratory Complications
timeFrame: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
Other outcomes:
Locations:
city: Mount Holly
country: United States
facility: Virtua Memorial Hospital
state: New Jersey
Study officials:
affiliation: Virtua Health, Inc.
name: Adam M Thaler, DO
role: PRINCIPAL_INVESTIGATOR
References: