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.: PACTR201604001595341 Date of Approval: 18/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title subarachnoid block for ex-preterm neonates.
Official scientific title Subarachnoid anesthesia (with and without sedation) versus general anesthesia for ex-preterm neonates undergoing elective infraumbalical surgeries.
Brief summary describing the background and objectives of the trial backgroud: Postoperative respiratory problems, especially apnea, is a common postoperative complication in formerly premature neonates undergoing infraumbalical surgeries. So, most of these neonates require close postoperative monitoring for at least 12 hours to avoid this hazard. Postoperative apnea is related more to the use of respiratory depressant drugs used during general anesthesia. ojective: To evaluate safety and effectiveness of spinal anesthesia in an ex-preterm infants undergoing infraumbalical surgeries and evaluate its role in elimination of routine postoperative hospital stay for apnea monitoring.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date 01/09/2016
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I Hyperbaric bupivacaine 0.5% (0.5 mg/kg) was injected in the subarachnoid space. patients received spinal anesthesia without sedation (only sugared pacifier was used). 35
Experimental Group Group II Hyperbaric bupivacaine 0.5% (0.5 mg/kg) was injected in subarachnoid space plus sedation in the form of ketamine (1 mg/kg) plus midazolam 50 mcg/kg. patients received spinal anesthesia with ketamine and midazolam sedation. 35
Control Group Group III patients who received general anesthesia with 2 MAC sevoflurane in 100 % oxygen and muscle relaxation with atracurium (induction dose 0.5mg/kg and maintenance dose 0.1mg/kg). patients received general anesthesia with caudal block. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. The age:formerly preterm neonates with post-conceptual age less than 60 weeks. . operation: infraumbalical surgery. . ASA: I - II . Sex: both sexes. . known allergy to local anesthetics . coagulopathy . pre-existing cardiac disease . metabolic disease . neuromuscular disease . uncontrolled convulsion .local infection at puncture site .parent refusal 0 Week(s) 60 Week(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 13/04/2016 Faculty of Medicine, Ain Shams University.
Ethics Committee Address
Street address City Postal code Country
Abbassia street Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative apnea, postoperative bradycardia and SPO2. up to 12 hours postoperatively.
Secondary Outcome The secondary outcome measures were postoperative complications (e.g. hypotension) and the need for postoperative respiratory support. up to 12 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine, Ain shams university Ramsis street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Ain Shams University Faculty of Medicine, Ain Shams University Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Ain Shams University Faculty of Medicine, Ain Shams University Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mansour Houssein Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University Cairo 11566 Egypt
Raham Hassan Mostafa Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University
City Postal code Country Position/Affiliation
Cairo 11566 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University
City Postal code Country Position/Affiliation
Cairo 11566 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 Department of anesthesia and intensive care, Faculty of Medicine, Ain Shams University
City Postal code Country Position/Affiliation
Cairo 11566 Egypt lecturer of anesthesia and intensive care
REPORTING
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