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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03276026
• Other study ID #: VirtuaHealth
• Status: Terminated
• Phase: Phase 4
• Start date: February 12, 2018
• Est. completion date: November 8, 2018

Study information

• Verified date: May 2019
• Source: Virtua Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: November 8, 2018
• Est. primary completion date: November 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Sugammadex
Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
• Neostigmine
Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.

Locations

Country	Name	City	State
United States	Virtua Memorial Hospital	Mount Holly	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Virtua Health, Inc.	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).