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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group/Neostigmine<br>The control group will be the 63 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg. | Drug: Neostigmine<br>* Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.<br>|
| Active Comparator: Study Group/Sugammadex<br>63 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four. | Drug: Sugammadex<br>* Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Anesthesia Care Unit Length of Stay | Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries. | Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Nausea and Vomiting | Assess the incidence of Postoperative Nausea and Vomiting in the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine at arrival to the post anesthesia care unit and every 15 minutes while in the post anesthesia care unit, with the prediction that there will be a lower incidence of Postoperative Nausea and Vomiting in the Sugammadex group. | Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes). | 
| Incidence of Respiratory Complications | Assess the incidence of respiratory complications postoperatively specifically looking at oxygen saturation at patient arrival to the post anesthesia care unit and every 15 minutes after arrival to the post anesthesia care unit and any intervention necessary. | Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugammadex, post anesthesia care unit recovery