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

Primary Purpose

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

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
Virtua Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring sugammadex, post anesthesia care unit recovery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virtua Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group/Neostigmine

Study Group/Sugammadex

Arm Description

The control group will be the 63 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 1, 2017
Last Updated
May 23, 2019
Sponsor
Virtua Health, Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03276026
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
PI left the Institution.
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
November 8, 2018 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virtua Health, Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Respiratory Conditions Due to Other External Agents
Keywords
sugammadex, post anesthesia care unit recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group/Neostigmine
Arm Type
Active Comparator
Arm Description
The control group will be the 63 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Arm Title
Study Group/Sugammadex
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Primary Outcome Measure Information:
Title
Post Anesthesia Care Unit Length of Stay
Description
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.
Time Frame
Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
Secondary Outcome Measure Information:
Title
Incidence of Postoperative Nausea and Vomiting
Description
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.
Time Frame
Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
Title
Incidence of Respiratory Complications
Description
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.
Time Frame
Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam M Thaler, DO
Organizational Affiliation
Virtua Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virtua Memorial Hospital
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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