Quality of Recovery After Reversal With Neostigmine or Sugammadex.

NCT02909439 | Completed Phase 4 Results DMC

• 1 other identifier: 917402-3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit.

Conditions

Incomplete Reversal of Neuromuscular Block

Outcome Measures

Primary Outcomes (3)

• Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes

  Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

  30 Minutes

• Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes

  Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

  60 Minutes after reversal

• Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes

  Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

  120 minutes after reversal

Secondary Outcomes (7)

• Grip Strength, Change From Baseline and Recovery Profile 30 Min

  30 minutes

• Grip Strength, Change From Baseline and Recovery Profile 60 Min

  60 minutes after reversal

• Grip Strength, Change From Baseline and Recovery Profile 120 Min

  120 minutes after surgery

• Time to Extubation

  Immediately after surgery, up to 30 minutes

• Train of Four Ratio > 90% During PACU Admission

  At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.

Study Arms (2)

Neostigmine

ACTIVE COMPARATOR

Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.

Drug: Neostigmine

Sugammadex

ACTIVE COMPARATOR

Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.

Drug: Sugammadex

Interventions

Sugammadex DRUG

Sugammadex will be given for reversal of neuromuscular blockade.

Also known as: Bridion

Sugammadex

Neostigmine DRUG

Neostigmine will be given for reversal of neuromuscular blockade.

Also known as: Prostigmine

Neostigmine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be willing and able to provide written informed consent for the study
• Participant must be greater than or equal to 18 years of age
• Participant must be ASA (American Society of Anesthesiologists) class I, II or III
• Planned use of neuromuscular blocking drugs
• Planned use of endotracheal intubation
• Planned for extubation to occur in the OR

You may not qualify if:

• ASA (American Society of Anesthesiologists) Class IV
• Age \< 18 years old
• Inability to give oral or written consent
• Known or suspected neuromuscular disorder impairing neuromuscular function
• True allergy to muscle relaxants
• A (family) history of malignant hyperthermia
• A contraindication for neostigmine or sugammadex administration
• Serum creatinine level of greater than 2.0 mg/dL
• Surgery where the patient's arm is not available for neuromuscular monitoring
• A plan to extubate under deep anesthesia
• Pregnant

Sponsors & Collaborators

• Stony Brook University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (3)

• Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.

  PMID: 25935840 BACKGROUND

• Farhan H, Moreno-Duarte I, McLean D, Eikermann M. Residual Paralysis: Does it Influence Outcome After Ambulatory Surgery? Curr Anesthesiol Rep. 2014 Dec;4(4):290-302. doi: 10.1007/s40140-014-0073-6.

  PMID: 25530723 BACKGROUND

• Abola RE, Romeiser J, Rizwan S, Lung B, Gupta R, Bennett-Guerrero E. A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength. Can J Anaesth. 2020 Aug;67(8):959-969. doi: 10.1007/s12630-020-01695-4. Epub 2020 May 13.

  PMID: 32405975 DERIVED

MeSH Terms

Interventions

Sugammadex; Neostigmine

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

Results Point of Contact

• Title: Ramon Abola, Clinical Associate Professor
• Organization: Stony Brook Medicine

ramon.abola@stonybrookmedicine.edu

631-444-2975

Study Officials

• Ramon Abola, MD

  Stony Brook Medicine, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2016
• Primary Completion: November 9, 2017
• Study Completion: February 1, 2018
• Last Updated: May 22, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)