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Deep Neuromuscular Block and Sugammadex Versus Standard of Care on Quality of Recovery in Patient Undergo Elective Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02648503
Recruitment Status : Unknown
Verified January 2016 by Phan Ton Ngoc Vu, Ho Chi Minh City University of Medicine and Pharmacy.
Recruitment status was:  Not yet recruiting
First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Phan Ton Ngoc Vu, Ho Chi Minh City University of Medicine and Pharmacy

Brief Summary:
Single center, prospective, randomized, single blinded, parallel group and controlled, assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex versus Standard of care on Quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery

Condition or disease Intervention/treatment Phase
Neuromuscular Block Drug: Deep neuromuscular block Drug: Moderate neuromuscular block Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep neuromuscular block
PTC=1-2
Drug: Deep neuromuscular block
Using rocuronium and reversal with sugammadex
Other Name: Esmeron and Bridion

Active Comparator: Moderate neuromuscular block
TOF=1-2
Drug: Moderate neuromuscular block
Using rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg)
Other Name: Esmeron and Neostigmin/Atropine




Primary Outcome Measures :
  1. Quality of recovery [ Time Frame: 40 minutes (T40) after the end of surgery ]

    The primary outcome is to access the differences of Quality of recovery in the overall recovery of the Post-operative Quality Recovery Scale (PQRS) instrument at 40 minutes (T40) after the end of surgery between Deep NMB (reversed with Sugammadex) and Standard of care in patients who undergo Laparoscopic Cholecystectomy.

    PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain. The Postoperative Quality Recovery Scale (PQRS) will be performed and recorded face-to-face by anesthesiologists in hospital and by telephone after discharge. The PQRS is completed prior to surgery to provide baseline values. Recovery is defined as returning to baseline values or better in each of the questions or assessments.



Secondary Outcome Measures :
  1. Quality of recovery [ Time Frame: 15 minutes (T15), and first day, 3 days after the end of surgery ]
    • The differences of Quality of recovery in the overall recovery of the PQRS instrument at 15 minutes (T15), and first day, 3 days after the end of surgery
    • The differences between each domain of PQRS instrument from 2 groups.

  2. Shoulder tip pain [ Time Frame: first hour, 6 hours and 24 hours after surgery ]
    using a 100 mm visual analogue scale (VAS) (0 indicating no pain and 100 worst imaginable pain)


Other Outcome Measures:
  1. Surgical condition [ Time Frame: intraoperation ]
    The satisfaction of surgeon with surgical condition from Deep Neuromuscular Block against Moderate Neuromuscular block. Surgeons will rate the surgical condition with a five-point surgical condition scale (SRS) ranging from 1= poor condition to 5= optimal surgical condition after the surgery

  2. Time to discharge readiness [ Time Frame: Every 20 min from the start of admission to the post-anesthesia care unit (PACU), up to 2 hours ]
    Time to discharge readiness from the post-anesthesia care unit (PACU) using Post Anesthesia Discharge Score System (PADSS)

  3. Duration of operation [ Time Frame: intraoperation ]
    Duration of surgery: from successful abdominal access with trocars to the skin closure Duration from reversal to extubation (TOF>0.9)



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

Inclusion Criteria:

  • All adult patients (> 18 years) scheduled for elective Laparoscopic Cholecystectomy with American Society of Anesthesiologist (ASA) class I-III in Hospital of University of Medicine and Pharmacy-Ho Chi Minh City

Exclusion Criteria:

  • Patients with ASA class IV
  • Age <18 years
  • Inability to inform consent
  • History or suspected with neuromuscular disorders
  • Allergies to rocuronium or sugammadex, anesthetics or narcotics drugs
  • A history of malignant hyperthermia
  • A contraindication with neostigmine administration
  • Pregnancy or breastfeeding
  • Renal and liver insufficiency are excluded from this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648503


Contacts
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Contact: Vu TN Phan, PhD. MD +84-908883458 vuphan682003@yahoo.com
Contact: Hung HM Phan, MD +84-938183079 phanhaminhhung@gmail.com

Locations
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Vietnam
Operation theathre
Ho Chi Minh, Vietnam, 700000
Contact: Vu TN Phan, PhD. MD    +84-90883458    vuphan682003@yahoo.com   
Sponsors and Collaborators
Ho Chi Minh City University of Medicine and Pharmacy
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Vu TN Phan, PhD. MD University medical center HCMC
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Responsible Party: Phan Ton Ngoc Vu, PhD. MD, Ho Chi Minh City University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT02648503    
Other Study ID Numbers: 8616-138
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Phan Ton Ngoc Vu, Ho Chi Minh City University of Medicine and Pharmacy:
Sugammadex
Post-operative Quality Recovery Scale (PQRS)
Additional relevant MeSH terms:
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Atropine
Rocuronium
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents