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

Phase 4
Terminated
Conditions
Postoperative Nausea and Vomiting
Respiratory Conditions Due to Other External Agents
Interventions
Registration Number
NCT03276026
Lead Sponsor
Virtua Health, Inc.
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
68
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control Group/NeostigmineNeostigmineThe control group will be the 63 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Study Group/SugammadexSugammadex63 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.
Primary Outcome Measures
NameTimeMethod
Post Anesthesia Care Unit Length of StayObservations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).

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.

Secondary Outcome Measures
NameTimeMethod
Incidence of Postoperative Nausea and VomitingObservations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).

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.

Incidence of Respiratory ComplicationsObservations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).

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.

Trial Locations

Locations (1)

Virtua Memorial Hospital

🇺🇸

Mount Holly, New Jersey, United States

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