Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

NCT03944473 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2019-10223
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ambulatory Difficulty

Keywords

high risk; chronic health condition; laparoscopic surgery

Outcome Measures

Primary Outcomes (3)

• Aldrete Score

  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

  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

  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 Outcomes (4)

• Rate of adverse events in PACU

  Up to 5 hours

• use of additional medications in PACU

  Up to 5 hours

• Emergency Department or inpatient admissions within 30 days after discharge

  30 days after discharge

• patient satisfaction

  Up to 5 hours

Study Arms (2)

neostigmine

ACTIVE COMPARATOR

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

sugammadex

EXPERIMENTAL

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

Interventions

Sugammadex DRUG

Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent

sugammadex

Neostigmine DRUG

Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent

neostigmine

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Related Publications (14)

• Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. doi: 10.1097/ACO.0b013e328010107e.

  PMID: 17093366 BACKGROUND

• Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.

  PMID: 28256998 BACKGROUND

• Watkins AC, White PF. Fast-tracking after ambulatory surgery. J Perianesth Nurs. 2001 Dec;16(6):379-87. doi: 10.1053/jpan.2001.28887.

  PMID: 11740779 BACKGROUND

• King M, Sujirattanawimol N, Danielson DR, Hall BA, Schroeder DR, Warner DO. Requirements for muscle relaxants during radical retropubic prostatectomy. Anesthesiology. 2000 Dec;93(6):1392-7. doi: 10.1097/00000542-200012000-00008.

  PMID: 11149431 BACKGROUND

• Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.

  PMID: 18635478 BACKGROUND

• Martinez-Ubieto J, Ortega-Lucea S, Pascual-Bellosta A, Arazo-Iglesias I, Gil-Bona J, Jimenez-Bernardo T, Munoz-Rodriguez L. Prospective study of residual neuromuscular block and postoperative respiratory complications in patients reversed with neostigmine versus sugammadex. Minerva Anestesiol. 2016 Jul;82(7):735-42. Epub 2015 Oct 16.

  PMID: 26472231 BACKGROUND

• Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.

  PMID: 25902322 BACKGROUND

• Brull SJ, Kopman AF. Current Status of Neuromuscular Reversal and Monitoring: Challenges and Opportunities. Anesthesiology. 2017 Jan;126(1):173-190. doi: 10.1097/ALN.0000000000001409.

  PMID: 27820709 BACKGROUND

• Hyman EC, Brull SJ. Clarification: Current Status of Neuromuscular Reversal and Monitoring, Challenges and Opportunities. Anesthesiology. 2017 Oct;127(4):730. doi: 10.1097/ALN.0000000000001795. No abstract available.

  PMID: 28926458 BACKGROUND

• Welliver M, Cheek D, Osterbrink J, McDonough J. Worldwide experience with sugammadex sodium: implications for the United States. AANA J. 2015 Apr;83(2):107-15.

  PMID: 26016169 BACKGROUND

• Soto R, Jahr JS, Pavlin J, Sabo D, Philip BK, Egan TD, Rowe E, de Bie J, Woo T. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial. Am J Ther. 2016 Nov/Dec;23(6):e1654-e1662. doi: 10.1097/MJT.0000000000000206.

  PMID: 25768376 BACKGROUND

• Cho HC, Lee JH, Lee SC, Park SY, Rim JC, Choi SR. Use of sugammadex in lung cancer patients undergoing video-assisted thoracoscopic lobectomy. Korean J Anesthesiol. 2017 Aug;70(4):420-425. doi: 10.4097/kjae.2017.70.4.420. Epub 2017 Apr 21.

  PMID: 28794837 BACKGROUND

• Sabo D, Jahr J, Pavlin J, Philip B, Shimode N, Rowe E, Woo T, Soto R. The increases in potassium concentrations are greater with succinylcholine than with rocuronium-sugammadex in outpatient surgery: a randomized, multicentre trial. Can J Anaesth. 2014 May;61(5):423-32. doi: 10.1007/s12630-014-0128-7. Epub 2014 Apr 8.

  PMID: 24710957 BACKGROUND

• Kim YH. Sugammadex: watch out for new side effects. Korean J Anesthesiol. 2016 Oct;69(5):427-428. doi: 10.4097/kjae.2016.69.5.427. Epub 2016 Sep 8. No abstract available.

  PMID: 27703621 BACKGROUND

MeSH Terms

Conditions

Mobility Limitation

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Curtis Choice, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Ambulatory Anesthesia Division

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 9, 2019
• Study Start: June 20, 2019
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share