Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

NCT ID: NCT02860507

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-28

Brief Summary

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

Detailed 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.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Neostigmine + Glycopyrrolate

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

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

Glycopyrrolate

Intervention Type: DRUG

sugammadex

Sugammadex 4mg/kg

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Interventions

sugammadex

Intervention Type: DRUG

Neostigmine

Intervention Type: DRUG

Glycopyrrolate

Intervention Type: DRUG

Other Intervention Names

Bridion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Enrico Camporesi

Attending Anesthesiologist & Director of Research, SE

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

TGH015

Identifier Type: -

Identifier Source: org_study_id