Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201510001292136 Date of Approval: 03/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade
Official scientific title Comparative study of Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in patients undergoing bronchoscopic lung biopsy
Brief summary describing the background and objectives of the trial Postoperative residual paralysis remains a common occurrence following the use of neuromuscular blocking agents (NMBAs), Rapid and complete reversal of neuromuscular blockade (NMB) is desirable at the end of surgery. Sugammadex reverses rocuronium-induced NMB by encapsulation. Prompt recovery of laryngeal reflexes and spontaneous respiration at the end of the interventional bronchoscopy procedures prevent adverse respiratory events Aim of the work The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in elderly patients undergoing lung biopsy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied lung biopsy,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/10/2015
Actual trial start date 09/03/2016
Anticipated date of last follow up 15/12/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using randomisation table Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RS 4.0 mg/kg over 10 seconds Anesthesia was induced with an IV 1 ¿g / kg fentanyl and IV propofol, and maintained using sevoflurane at 1¿2 minimum alveolar anesthetic concentration (MAC). Neuromuscular blockade will be achieved with 0.6 mg kg¿1rocuronium and will be monitored with train-of-four. At reappearance of ¿1-2 posttetanic counts after last rocuronium dose Sugammadex will be given over 10 seconds IV 30
Control Group RN 50 ¿g / kg neostigmine+ atropine 1mg/kg over 10 seconds Neuromuscular blockade will be achieved with 0.6 mg kg¿1rocuronium and will be monitored with train-of-four. At reappearance of ¿1-2 posttetanic counts after last rocuronium dose neostigmine will be given over 10 seconds IV for reversal of rocuronium. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA III&IV adult patients over 60 years undergo bronchoscopic lung biopsy a difficult airway known or suspected neuromuscular disorders significant renal dysfunction patients receiving medication likely to interfere with rocuronium 60 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/10/2015 ethics committee faculty of medicine alexandria university
Ethics Committee Address
Street address City Postal code Country
el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome is to measure the time to reach train-of-four > 0.9 at the end of suergery from giving the study drug till the time to reach train-of-four > 0.9
Secondary Outcome blood gas analysis at the time of discharge from PACU
Secondary Outcome peak expiratory flow rate at the time of discharge from PACU
Secondary Outcome Symptoms of pulmonary complications within 7 postoperative days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university hospital al azerita square alexandria 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
el Faculty of Medicine, University of Alexandria, Egypt el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor shahira el metainy el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
reahab abdel raof el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shahira el metainy shelmetainy@yahoo.com +01223527804 el azerita square Faculty of Medicine, University of Alexandria, Egypt
City Postal code Country Position/Affiliation
alexandria 0000 Egypt Department of Assistant Professor Anaesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries shahira el metainy shelmetainy@yahoo.com +01223527804 el azerita square Faculty of Medicine, University of Alexandria, Egypt
City Postal code Country Position/Affiliation
alexandria Egypt Department of Assistant Professor Anaesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries shahira el metainy shelmetainy@yahoo.com +01223527804 el azerita square Faculty of Medicine, University of Alexandria, Egypt
City Postal code Country Position/Affiliation
alexandria Egypt Assistant Professor Anaesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Scientific Enquiries rehab abdelraof trcium2002@yahoo.com +01001073703 el azerita square Faculty of Medicine, University of Alexandria, Egypt
City Postal code Country Position/Affiliation
alexandria Egypt lecturer Department of Anaesthesia and Surgical Intensive Care
REPORTING
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