The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal

August 3, 2021 updated by: Jarrett Heard, Ohio State University

The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal in Outpatient Surgeries - An Evaluation of Clinical and Associated Health Care Cost

Patients who undergo surgery receive drugs called neuromuscular blocking agents (NMBA) that to block the activity of muscles. When the surgery is over, the block needs to be reversed. Suggammadex and neostigmine are examples of drugs that reverse blocks. This study aims to investigate if sugammadex is associated with a significantly reduced time to discharge from the operating room to the postoperative unit when compared to neostigmine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, randomized, double arm prospective clinical trial involving adult patients undergoing outpatient surgeries at The OSUWMC. Institutional review board (Office of Responsible Research practices) approval is mandatory preceding the start of the clinical trial. Written informed consent will be obtained from all eligible patients participating in this trial, and signed prior to the initiation of any study-related procedures. The study will be conducted in accordance with the principles of Good Clinical Practice and will be approved by the appropriate institutional review boards at OSUWMC. An individual with appropriate human subjects protection and HIPAA education will undertake the consent process in the surgeon's office or other appropriate location (e.g. preoperative clinics). Researchers will utilize the electronic medical record (EMR) to screen and identify surgical cases based on study inclusion criteria. These cases will be reviewed together with the surgical team to determine whether all inclusion and exclusion criteria are met, prior to approaching the patient. Prior surgery, a study-team investigator will approach the patient to discuss the nature of the study, its requirements, and potential risks. Written informed consent will be obtained from every subject prior to the start any study related procedures and enough time will be allowed for the subject to ask questions and receive answers. The inclusion and exclusion criteria will be reviewed in order to ascertain whether a patient qualifies for this study. Subjects must meet all the inclusion criteria and none of the exclusion criteria to qualify for the study.

  • All medication taken 7 days prior surgery will be recorded. Demographic information, previous medical history, vital signs, urine pregnancy test, and a physical examination will be performed at this time as a standard of care and results will be recorded.
  • Study medication dosages will be calculated prior to surgery by using total body weight (TBW) by the research team, following standard operational procedures.

II.4.B. Intraoperative phase

  • Pre-induction: intravenous midazolam (2 - 4 mg) if required.
  • Induction of general anesthesia: anesthesia will follow the standard of care protocols set by our center. Therefore, preoxygenation will be achieved with 100% oxygenation for at least 5 full Tidal Volume and suggested dosage of anesthetic drugs will be as follows: propofol 1-2 mg/kg, lidocaine IV 40-100 mg, fentanyl IV 1-2 μg/Kg, and sevoflurane 0.5-1 MAC (if needed). Additionally, rocuronium (0.3-0.7 mg/kg) will be used for neuromuscular blockade in all patients.
  • Maintenance of general anesthesia: balanced anesthesia will be administered for maintenance at the anesthesiologists' discretion. We suggest the following regimen: sevoflurane (0.5-1 MAC), remifentanil IV 0.05-0.25 μg/kg/min, and propofol IV 20-75 μg/kg/min. In accordance with guidelines for Good Clinical Practices in pharmacodynamic studies of NMBA, neuromuscular monitoring will be assessed via the train-of-four (TOF) stimulation. TOF device will be placed on the ulnar nerve to illicit twitches in the adductor pollicis. The response to TOF stimulation will be assessed by the anesthesiologist every 30 minutes, starting at intubation. If second response reappears in the TOF stimulation, supplemental doses of rocuronium will be administered at anesthesiologists' discretion.

  • Neuromuscular blockade reversal: after peritoneal (port sites) closure, TOF will be assessed. Exact doses of the study medications (previously determined by total body weight) will be administered as following:

    • Sugammadex:

      • If spontaneous recovery has reached second twitch after TOF: 2 mg/kg
      • If spontaneous recovery has reached between 1-2 post-tetanic counts but no twitch responses to TOF: 4 mg/kg
      • When there is a clinical need to reverse NMB within 3 min of a single dose of rocuronium (1.2 mg/kg): 16 mg/kg
    • Neostigmine: 50 µg. Kg-1 will be administered after spontaneous recovery has reached fourth twitch after TOF in accordance with our institutional standard procedures and published literature [10, 11]
  • After IP administration, TOF will be assessed every 30 seconds during the first 3 minutes and every minute afterwards to TOF value ≥ 0.9

  • The following variables will be collected:

    • Time from peritoneal closure (port sites) to anesthesia readiness for OR discharge to PACU
    • Time from IP administration to extubation
    • Time from IP administration to TOF ≥ 0.9
    • Time from IP administration to anesthesia readiness for OR discharge to PACU II.4.C. Postoperative phase (Postoperative Care Unit)
  • The modified Aldrete score will be documented in the EMR.
  • Time to discharge-readiness from the OR to PACU, admission time to PACU, and time to discharge from the hospital will be recorded.
  • Perioperative incidence of IP related adverse events (i.e. bradycardia, anaphylaxis, nausea and vomiting, and hypotension) Summary statistics will be calculated and reported as means (standard deviations) or medians [inter-quartile ranges] for continuous variables and as frequencies (percentages) for categorical variables. Study groups will be compared using Student's t-tests or Wilcoxon Rank-Sum tests for continuous variables and chi-squared or Fisher's exact tests for categorical variables where appropriate. Primary hypotheses comparing time from peritoneal closure (port sites) to anesthesia readiness for OR discharge to PACU between study groups will be tested using Student's unpaired t-tests (on the natural log transformed outcomes if necessary) at the 5% type I error rate. All analyses will be conducted using SAS version 9.4 (SAS Institute, Cary, N.C.) The study will last approximately one year including recruitment, analysis of the data and writing of the manuscript.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects undergoing outpatient surgeries (laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy) under general anesthesia requiring rocuronium-induced neuromuscular blockade
  2. Male or female patient 18 years and older
  3. Able to consent
  4. American Society of Anesthesiologist (ASA) physical status of I, II, or III

Exclusion Criteria:

  1. Participating in another interventional study drug within 30 days prior to their recruitment
  2. Special population (Pregnant, Inmate, Breastfeeding)
  3. History of allergy to sugammadex or rocuronium
  4. Any medication known to interfere with NMBA or sugammadex
  5. Presence of any clinical condition as determined by the investigator that exclude the patient from the trial such as COPD, CKD, and neuromuscular or neurodegenerative diseases

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sugammadex
  • If spontaneous recovery has reached second twitch after TOF: 2 mg/kg
  • If spontaneous recovery has reached between 1-2 post-tetanic counts but no twitch responses to TOF: 4 mg/kg
  • When there is a clinical need to reverse NMB within 3 min of a single dose of rocuronium (1.2 mg/kg): 16 mg/kg
Drug: Sugammadex vs Neostigmine
Patients will be randomized into either Sugammadex or Neostigmine neuromuscular blockade reversal.
Active Comparator: Neostigmine
50 µg. Kg-1 will be administered after spontaneous recovery has reached fourth twitch after TOF in accordance with our institutional standard procedures and published literature.
Drug: Sugammadex vs Neostigmine
Patients will be randomized into either Sugammadex or Neostigmine neuromuscular blockade reversal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sugammadex blockade reversal reduce discharge to PACU.
Time Frame: 1 hour
Time from peritoneal closure (port sites) to anesthesia readiness for OR discharge to PACU
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation time
Time Frame: 1 hour
Time from IP administration to extubation
1 hour
TOF less than 0.9
Time Frame: 1 hour
Time from IP administration to TOF ≥ 0.9
1 hour
PACU
Time Frame: 1 hour
Time from IP administration to anesthesia readiness for OR discharge to PACU
1 hour

Collaborators and Investigators

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

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Sergio D Bergese, MD, The Ohio State University Wexner 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 (Actual)

August 15, 2018

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018H0102

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.

No

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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