Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries (Sugammadex)

November 14, 2019 updated by: Curtis Choice, Montefiore Medical Center

Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.

The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

There is limited published data in the use of sugammadex for high-risk patient populations, such as those undergoing laparoscopic procedures in standalone outpatient surgery facilities. About 90% of the ambulatory surgical patient population at this institution is non-caucasian with the majority of the higher-risk patients having obesity and one or more additional chronic health conditions. In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.

The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

In this double-blinded randomized controlled study, the study team is evaluating the efficacy and safety of sugammadex in patients undergoing ambulatory surgical procedures. Currently, both neostigmine and sugammadex are standard of care in this institution. Other than the emergent need for NMB reversal, practice preference and individual indications dictate the selection of reversal medication.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical score II and III
  • Scheduled for a laparoscopic ambulatory surgery
  • 21-60 years of age
  • Able to understand and sign informed consent

Exclusion Criteria:

  • Known allergy to neostigmine or sugammadex
  • Active pulmonary diagnosis
  • American Society of Anesthesia physical score 4 and above
  • Known or suspected neuromuscular disease
  • Documented renal or liver insufficiency (2 fold increase in the labs)
  • Body Mass Index >40
  • Any surgical case brought into the operating room after 4 PM (to avoid any provider bias related to discharging patients before closure of the ambulatory surgery center for the day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: neostigmine
Neostigmine is the acetylcholinesterase inhibitor most commonly used in pharmacologically reversing the effects of neuromuscular blockers [8]. Reversal of NMB is facilitated by increasing acetylcholine levels at nicotinic skeletal muscle-binding sites.
Drug: Neostigmine
Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent
Experimental: sugammadex
Sugammadex is a modified gamma-cyclodextrin, the first of a new class of drugs called selective relaxant binding agents, with an unusually high affinity for rocuronium. This medication offers an alternate mechanism of action to antagonize the effects of steroidal neuromuscular blockade agents.
Drug: Sugammadex
Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aldrete Score
Time Frame: Up to 5 hours
The Aldrete Score will determine transfer from phase 1 to phase 2 recovery. The following criterias will be scored from 0 to 2- activity level, respiration, blood pressure, consciousness, oxygen saturation. Patients who get a total score of 9 or more are considered ready for discharge from Post Anesthesia Care Unit
Up to 5 hours
Post Anesthetic Discharge Scoring System
Time Frame: Up to 5 hours
The Post Anesthetic Discharge Scoring System (PADSS) will be used to determine discharge to home readiness. Six criterias to score- vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each one is given a score from 0 to 2. Patients who get a total score of 9 or more are considered ready for discharge from Post Anesthesia Care Unit
Up to 5 hours
Fit To PACU Discharge
Time Frame: Up to 5 hours
Based on Post Anesthetic Discharge Scoring System (PADSS), the primary outcome measure will be calculated as the time from study medication administration to the time of "fit to discharge from Post Anesthesia Care Unit (PACU)."
Up to 5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse events in PACU
Time Frame: Up to 5 hours
The research associate will record the adverse events related to delay in discharge during stay in Post Anesthesia Care Unit (PACU)
Up to 5 hours
use of additional medications in PACU
Time Frame: Up to 5 hours
The research associate will record any medications used in the Post Anesthesia Care Unity (PACU).
Up to 5 hours
Emergency Department or inpatient admissions within 30 days after discharge
Time Frame: 30 days after discharge
One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.
30 days after discharge
patient satisfaction
Time Frame: Up to 5 hours
At the time of discharge from PACU when patients are fully recovered and conscious, a validated satisfaction survey will be administered.
Up to 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Curtis Choice, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 20, 2019

Primary Completion (Anticipated)

July 20, 2020

Study Completion (Anticipated)

July 20, 2020

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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