Ambulatory Difficulty Clinical Trial
— SugammadexOfficial title:
Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Verified date | November 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 20, 2020 |
Est. primary completion date | July 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Montefiore Medical Center |
Brull SJ, Kopman AF. Current Status of Neuromuscular Reversal and Monitoring: Challenges and Opportunities. Anesthesiology. 2017 Jan;126(1):173-190. Review. — View Citation
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. — View Citation
Fortier LP, McKeen D, Turner K, de Médicis É, 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. — View Citation
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. — View Citation
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. — View Citation
Kim YH. Sugammadex: watch out for new side effects. Korean J Anesthesiol. 2016 Oct;69(5):427-428. Epub 2016 Sep 8. — View Citation
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. — View Citation
Martinez-Ubieto J, Ortega-Lucea S, Pascual-Bellosta A, Arazo-Iglesias I, Gil-Bona J, Jimenez-Bernardó T, Muñoz-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. — View Citation
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. — View Citation
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. — View Citation
Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006 Dec;19(6):622-9. Review. — View Citation
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. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Rate of adverse events in PACU | 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 | |
Secondary | use of additional medications in PACU | The research associate will record any medications used in the Post Anesthesia Care Unity (PACU). | Up to 5 hours | |
Secondary | Emergency Department or inpatient admissions within 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 | |
Secondary | patient satisfaction | 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 |
Status | Clinical Trial | Phase | |
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Enrolling by invitation |
NCT05736484 -
Randomized Clinical Trial to Improve Mobility After Hospitalization
|
N/A |