Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
 
ClinicalTrials.gov Identifier: NCT02860507
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Study Documents (Full-Text)

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


Publications:

Layout table for additonal information
Responsible Party: Enrico Camporesi, Attending Anesthesiologist & Director of Research, SE, University of South Florida
ClinicalTrials.gov 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:
Layout table for MeSH terms
Glycopyrrolate
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists