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.: PACTR201809879218534 Date of Approval: 25/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Determining the minimum dose required of Remifentanil to obtain adequate intubating conditions in children presenting for day case surgery - a randomised controlled trial
Official scientific title Determining the minimum dose required of Remifentanil to obtain adequate intubating conditions in children presenting for day case surgery - a randomised controlled trial
Brief summary describing the background and objectives of the trial The aim of this research project is to determine the minimum dose required to successfully intubate a child presenting for day case surgery without the use of neuromuscular blocking agents. The objective will be inducing children presenting for day case surgery, as is usually done, but each child will be placed in one of three dosing groups to determine what the minimum required dose will be.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2018
Actual trial start date 18/07/2018
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Remifentanil 0.50; 0.75 and 1.0 ug/kg as a once off bolus dose at induction of anaesthesia Once off bolus dose Bolus dose at induction of anaesthesia as determined by randomisation. 80
Control Group No remifentanil none not applicable not applicable 80 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria include: Patients aged three to ten years of age, Elective dental/maxillofascial surgery, ASA 1 and 2 patients, Patients fasted according to current guidelines (Milk and solid food is six hours; breastmilk is four hours; clear fluids is two hours) Exclusion criteria is as follows: Parental/guardian refusal Patient refusal, If the patient is allergic to any of agents used in this study, Patient not in specified age group, Bacterial or viral upper/lower respiratory tract infection, Difficult airway, Patients known with or a family history of anaesthetic complications such as porphyria or malignant hyperthermia, Patients known with obstructive sleep apnoea or at risk of developing obstructive sleep apnoea, Patients with heart murmurs that have not yet been investigated and diagnosed, Patients with congenital heart disease, Any patient at risk of aspiration (due to not being starved or due to a medical condition such as diabetes mellitus) Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 10 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 31/05/2018 The Research Ethics Committee Faculty of Health Sciences University of Pretoria
Ethics Committee Address
Street address City Postal code Country
Tswelopele Building, Level 4, Room 60 / 61, 31 Bophelo Road, Gezina, Pretoria, 0002 Pretoria 0002 South Africa
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 31/05/2018 The Research Ethics Committee Faculty of Health Sciences University of Pretoria
Ethics Committee Address
Street address City Postal code Country
Tswelopele Building, Level 4, Room 60 / 61, 31 Bophelo Road, Gezina, Pretoria, 0007 Pretoria 0007 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the minimum required dose of remifentanil needed for intubation in children presenting for day case surgery without the use of neuromuscular blocking agent During induction of anaesthesia
Secondary Outcome To determine the dose of remifentanil for effective intubation with the least haemodynamic interference. During induction of anaesthesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oral and Dental Hospital University of Pretoria 1 Bophelo Road Pretoria 0002 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Pretoria Faculty of Health Sciences HW Snyman South Building University of Pretoria, Bophelo Road Pretoria 0084 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karen Van der Stockt karenvdsice@gmail.com +27722625032 341 Aquila Avenue, Waterkloof Ridge
City Postal code Country Position/Affiliation
Pretoria 0181 South Africa Investigator and Registrar in Anaesthesia at University of Pretoria
Role Name Email Phone Street address
Scientific Enquiries Johannes Marthinus Dippenaar tinus.dippenaar@up.ac.za 0123541510 Oral and Dental Hospital 1 Bophelo Road
City Postal code Country Position/Affiliation
Pretoria 0084 South Africa Principal Specialist Clincial head Anaesthesiology Dept Maxillo Facial Oral Surgery
Role Name Email Phone Street address
Public Enquiries Karen Van der Stockt karenvdsice@gmail.com +27722625032 341 Aquila Avenue, Waterkloof Ridge
City Postal code Country Position/Affiliation
Pretoria 0181 South Africa Registrar in Anaesthesia at the University of Pretoria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information