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Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

Sponsor
Montefiore Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03944473
Collaborator
(none)
0
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
On the day of surgery, an envelope containing the randomization code will be given to an anesthesiology physician or nurse anesthetist responsible for the clinical care of the study patient. Patients will be randomly allocated to receive neostigmine or sugammadex using a 1:1 allocation ratio. Patients will be stratified based on their ASA physical score. A research associate who is not directly involved with the study procedures will maintain the randomization codes. All others will be blinded
Primary Purpose:
Other
Official Title:
Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Anticipated Study Start Date :
Jun 20, 2019
Anticipated Primary Completion Date :
Jul 20, 2020
Anticipated Study Completion Date :
Jul 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Aldrete Score [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

  2. Post Anesthetic Discharge Scoring System [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

  3. Fit To PACU Discharge [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)."

Secondary Outcome Measures

  1. Rate of adverse events in PACU [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)

  2. use of additional medications in PACU [Up to 5 hours]

    The research associate will record any medications used in the Post Anesthesia Care Unity (PACU).

  3. Emergency Department or inpatient admissions within 30 days after discharge [30 days after discharge]

    One month ED visits and inpatient admissions for a pulmonary diagnosis will be collected from the medical records.

  4. patient satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Curtis Choice, Director, Ambulatory Anesthesia Division, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT03944473
Other Study ID Numbers:
  • 2019-10223
First Posted:
May 9, 2019
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Curtis Choice, Director, Ambulatory Anesthesia Division, Montefiore Medical Center
high risk
chronic health condition
laparoscopic surgery
Additional relevant MeSH terms:
Mobility Limitation
Neostigmine

Study Results

No Results Posted as of Nov 18, 2019