Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

University of South Florida

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: sugammadex; Drug: Glycopyrrolate; Drug: Neostigmine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02860507

TGH015

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Full description

Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for open ventral hernia repair or open colectomy
• ASA class I-III
• 18 years and older
• Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg
• Subjects who have given written informed consent

Exclusion criteria

• Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
• Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1
• Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
• Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;
• Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients
• Subjects who have a contraindication to, Rocuronium or Sugammadex
• Female subjects who are pregnant
• Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Neostigmine + Glycopyrrolate

Active Comparator group

Description:

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Treatment:

Drug: Glycopyrrolate

Drug: Neostigmine

sugammadex

Experimental group

Description:

Sugammadex 4mg/kg

Treatment:

Drug: sugammadex