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Trial record 35 of 186 for:    GLYCOPYRROLATE

Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02860507
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida

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

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: sugammadex Drug: Neostigmine Drug: Glycopyrrolate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Double Blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, Care Providers, Investigators, and Outcome Assessors are blinded from the type of NMBA reversal agent used prior to completion of data collection
Primary Purpose: Treatment
Official Title: A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency
Actual Study Start Date : August 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Neostigmine + Glycopyrrolate
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Drug: Neostigmine
Drug: Glycopyrrolate
Experimental: sugammadex
Sugammadex 4mg/kg
Drug: sugammadex
Other Name: Bridion

Primary Outcome Measures :
  1. Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate. [ Time Frame: through start of next surgery, average of 2 hours ]

Secondary Outcome Measures :
  1. Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications [ Time Frame: through discharge from hospital, average of 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Study Documents (Full-Text)

Documents provided by Enrico Camporesi, University of South Florida:
Informed Consent Form  [PDF] December 16, 2015


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Responsible Party: Enrico Camporesi, Attending Anesthesiologist & Director of Research, SE, University of South Florida Identifier: NCT02860507     History of Changes
Other Study ID Numbers: TGH015
First Posted: August 9, 2016    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists