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

NCT03276026 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: VirtuaHealth
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sugammadex; post anesthesia care unit recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Postoperative Nausea and Vomiting

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

• Incidence of Respiratory Complications

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

Study Arms (2)

Control Group/Neostigmine

ACTIVE COMPARATOR

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

Study Group/Sugammadex

ACTIVE COMPARATOR

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

Interventions

Sugammadex DRUG

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

Study Group/Sugammadex

Neostigmine DRUG

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

Control Group/Neostigmine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virtua Health, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Adam Thaler
• Organization: Jefferson

thaler.adam@gmail.com

215-901-0749

Study Officials

• Adam M Thaler, DO

  Virtua Health, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 8, 2017
• Study Start: February 12, 2018
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-05

Locations

US (1)