Comparison of Sugammadex and Neostigmine During PACU Stay

NCT04096144 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 41493
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Sugammadex was approved for post-operative use in the operating room (OR) and post-anesthesia recovery unit (PACU) of our quaternary facility, Tampa General Hospital. The approval came with administrative limitations: 2mg/kg dose only and for the first year its utilization was limited as replacement for up to half of Neostigmine/Glycopyrrolate use. An MUE evaluation was completed for a retrospective chart review from March 2017 to December 2017 (10 months) to assess all cases in which patients received Sugammadex or Neostigmine. During the year of data collection, we also noted a widespread tendency to reduce the usage of narcotics. A t-test comparison of the length of stay (LOS) in the PACU revealed a highly significant difference between the LOS in PACU for both drugs. On average, patients receiving Sugammadex were discharged from the PACU 43 minutes earlier than patients who received Neostigmine/Glycopyrrolate. The patient mix in both groups was similar, but these data were obtained retrospectively by a pharmacy chart review.

Conditions

Neuromuscular Blockade

Keywords

Post anesthesia care unit; sugammadex; neostigmine; neuromuscular reversal

Outcome Measures

Primary Outcomes (5)

• Length of Post Anesthesia Care Unit (PACU) stay

  Time spent in the recovery room (PACU).

  6 months

• Pain (Visual Analog Scale) VAS scores

  Evaluation of the level of pain

  6 months

• Aldrete Score

  Evaluation of level of alertness of the patient at the conclusion of PACU stay for discharge.

  6 months

• Pulse Oximetry

  Finger Saturation

  6 months

• Blood Pressure upon PACU discharge

  Evaluation of Blood Pressure at the conclusion of PACU stay.

  6 months

Study Arms (2)

Neostigmine

EXPERIMENTAL

This is the standard Neuromuscular reversal drug that has been in standard care for the past thirty years. Dose: -Neostigmine: 0.03-0.07 mg/kg by intravenous route.

Drug: Neuromuscular Blocking Agents

Sugammadex

EXPERIMENTAL

Used for Neuromuscular reversal; Sugammadex is devoid of the parasympathetic effects caused by Neostigmine. Dose: -Sugammadex: 2-4 mg/kg (4 mg/kg if no twitch responses after initial stimulation), intravenous route.

Drug: Neuromuscular Blocking Agents

Interventions

Neuromuscular Blocking Agents DRUG

Neuromuscular agents will be used to block muscle function for the safety and efficiency of the procedure. At the procedure's conclusion, neuromusclar agents such as Neostigmine or Sugammadex will be used to reverse the neuromuscular reversal.

Neostigmine; Sugammadex

Eligibility Criteria

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

You may qualify if:

• years of age
• Patients with surgeries with duration of 90-120 minutes
• ASA Patients I-III (Appendix A)
• Patients admitted to TGH for abdominal hernia repair, cholecystectomy and/or abdominal surgery as performed by Dr. Albrink
• BMI \> 30

You may not qualify if:

• \<18 years of age
• ASA Patients IV and above (Appendix A)
• Patients with allergic reactions to Neostigmine+Glycopyrrolate and/or Sugammadex

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (2)

• Enten G, Albrink M, Deng J, Melloni G, Camporesi EM, & Mangar D. Sugammadex Administration Shortens Reversal Times but not OR Turnover Times. Case Studies in Surgery. 2019 Jul;5(1): 27.

  BACKGROUND

• Presented at 2019 American Society of Anesthesiologists meeting: Mangar D, Pease S, Guzman S, Abowali H, Balouch M, & Camporesi EM. PACU Length of Stay after Neuromuscular Blocker Reversal with Sugammadex. Orlando, FL.

  BACKGROUND

MeSH Terms

Interventions

Neuromuscular Blocking Agents

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Enrico M Camporesi, MD

  TEAMHealth Anesthesia/Tampa General Hospital

  PRINCIPAL INVESTIGATOR

• Maha Balouch, MA

  TEAMHealth Anesthesia/Tampa General Hospital

  STUDY CHAIR

• Michael Albrink, MD

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico M Camporesi, MD

CONTACT

8136009094; ecampore@health.usf.edu

Maha Balouch, MA

CONTACT

8137315810; maha_balouch@teamhealth.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 19, 2019
• Study Start: October 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 15, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)