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

NCT ID: NCT03276026

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2018-11-08

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group/Neostigmine

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

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

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

Study Group/Sugammadex

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.

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

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

Interventions

Sugammadex

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

Intervention Type: DRUG

Neostigmine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Virtua Health, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam M Thaler, DO

Role: PRINCIPAL_INVESTIGATOR

Virtua Health, Inc.

Locations

Virtua Memorial Hospital

Mount Holly, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VirtuaHealth

Identifier Type: -

Identifier Source: org_study_id