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.: PACTR201907523457024 Date of Approval: 22/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title spinal anesthesia in paediatrics
Official scientific title A Comparison between Spinal Anesthesia and General Anesthesia in pediatrics undergoing infraumblical surgeries
Brief summary describing the background and objectives of the trial Spinal anesthesia (SA) in pediatrics started to be used in the late nineteenth century in several procedures including intra-abdominal and lower limb surgeries with success rate 93 – 95%. The priority was for high-risk and former preterm infants, for its suggested protective role compared to general anesthesia (GA) with the risk for development of postoperative apnea, but still bradycardia and hypotension remain potential side effects. Postoperative apnea, is defined as cessation of breathing or detection of air flow of ≥ 15 sec or < 15 sec with bradycardia. It is considered a vital complication in young infants and the risk is more in neonates who were premature. This leads to the recommendation that formerly premature infants should be monitored in hospitals after elective surgery. It is not certain whether postoperative apnea is the result of the unmasking of immature respiratory control by residual general anesthetic effects, pain, neurohumoral substances, or other factors. Decreasing the risk of apnea and recognizing infants at risk of apnea may reduce morbidity and guide clinicians on the optimal age for surgery and the length and intensity of postoperative observation. Awake regional anesthesia (RA) may decrease the risk of apnea. Therefore our study is designed to evaluate and compare the effect of spinal anesthesia and general anesthesia on reducing the postoperative apnea in pediatrics. So we hypothesized that Spinal anaesthesia would protect babies from postoperative apnea,.which is common with general anaesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Spinal Anaesthesia SA
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial spinal anaesthesia in paediatrics
Anticipated trial start date 22/07/2019
Actual trial start date 22/07/2019
Anticipated date of last follow up 05/09/2019
Actual Last follow-up date 03/10/2019
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants) 36
Recruitment status Completed
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anethesia Inhalational induction and maintenance by sevoflurane allover the surgery Careful medical history and physical examination will be done. Informing the parents that fasting hours are 6 hours for artificial formula and 4 hours for breast-milk. Explaining the method of anesthesia to parents and reassuring them. The operating theater temperature will be controlled to be warm enough to the patient. Babies will be monitored by pulse oximeter, ECG, temperature, non-invasive blood pressure, capnogram and precordial stethoscope. An intravenous line by 22G or 24G cannula will be established. Patients will be pre-medicated with atropine 0.01mg/kg. Patients will receive anesthesia induction by sevoflurane. Then patients will be intubated by the oral endotracheal tube that fits them. The maintenance of anesthesia will be achieved by using isoflurane through the same circuit system at the same flow rate to achieve MAC of 1.2% and the patients will be mechanically ventilated on BIPAP mode. Patients will receive paracetamol infusion with a dose of 15 mg/kg for analgesia via IV accesses. 19 Active-Treatment of Control Group
Experimental Group spinal anesthesia hyperbaric bupivacaine 0.5% will be injected in a dose calculated as 1 mg/kg body weight at the induction of anesthesia and its effect continues throughout the surgery Careful medical history and physical examination will be done. Informing the parents that fasting hours are 6 hours for artificial formula and 4 hours for breast-milk. Explaining the methods of anesthesia to parents and reassuring them. A written consent from the parents will be taken. The operating theatre temperature will be controlled to be warm enough to the patient. Babies will be monitored by pulse oximeter, ECG, temperature, non-invasive blood pressure and precordial stethoscope. All general anesthesia equipment and resuscitative drugs will be prepared. An intravenous line by 22G or 24G cannula will be established. Patients will be pre-medicated with atropine 0.01mg/kg and 0.5-1 ml EMLA TM cream will be applied to the lumber region 1 hour before the procedure. The patients will be positioned in lateral position with head extension and hip flexion, held by the nurse. After careful disinfection of the back with Betadine solution, Lumbar puncture will be done at L4-L5 interspace by midline approach using 38 mm, 25G or 27G Quincke spinal needles. After getting free CSF, a hyperbaric bupivacaine 0.5% will be injected in a dose calculated as 1 mg/kg body weight, as the patients' weight is less than 5 kg. Patient will be put in supine position immediately after injection, with gentle fixation of legs to prevent movements of patient till stabilizing the level. The sensory level will be assessed by firm skin pinch and pin prick test, the motor level will be assessed by observation of the lower limb movement in response to pin prick. 19
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
* Neonates with physical status American society of anesthesiologists 1 or 2 (ASA 1 or ASA 2). ASA1: normal healthy patient. ASA 2: patient with mild systemic disease without functional limitations. * Both genders. * Age groups: 0 to 28 days of life * babies born at or after 35 weeks. * Operations that presume less than 90 minutes. * Contraindications of spinal anesthesia: - Infection at the site of infection. - Coagulopathy. * babies with craniofascial anomalies * Obese babies, whose BMI at or above the 95th percentile for children of the same age and sex. * Babies with obstructive sleep apnea * Known history of allergy to the used drugs; hyperbaric bupivacaine. * preterm babies, who born before 35 weeks. * Refusal of parents to participate in study. New born: 0 Day-1 Month 0 Day(s) 1 Month(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 31/01/2019 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road, Ismailia, Egypt Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome detecting postoperative apnea in both groups since the end of surgery till 6 hours postoperatively
Secondary Outcome Post-operative pain assessment since recovery till 24 hrs postoperatively
Secondary Outcome nausea and vomitting since recovery till 24hrs postoperatively
Secondary Outcome 1st time of feeding after recovery after recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals Kilo 4.5, Ring road Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Kilo 4.5, Ring Road Ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospitals Kilo 4.5, Ring road Ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Hosny Ahmed Ali Kilo 4.5, Ring road Ismailia 41522 Egypt
Shimaa Ahmed Hamed Al Touny shebeen elkoom st. building No. 1 Ismailia 41522 Egypt
Medhat Lamei Shaker Kilo 4.5, Ring road Ismailia 41522 Egypt
Ezzat Mohamed El Taher Kilo 4.5, Ring road Ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Hosny m.hosnawy208@gmail.com +201097920831 Kilo 4.5, Ring Road
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt resident of anesthesia
Role Name Email Phone Street address
Principal Investigator Shimaa Al Touny shimaa_touny@yahoo.com +201004042654 sheben elkoom st., building No.1
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt lecturer of anethesia and ICU
Role Name Email Phone Street address
Public Enquiries Medhat Lamei Dr.medhat.shaker@hotmail.com +201015177218 kilo 4.5, Ring Road
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Lecturer of Anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Ezzat El Taher Ezzatme@gmail.com +201007336217 Kilo 4.5, Ring road
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Professor of Anesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD that underlie results in a publication Informed Consent Form,Study Protocol beginning 9 months and ending 36 months following article publication For investigators whose proposed use of the data has been approved by an independent review committee. For individual participant data meta-analysis. Proposal may be submitted up to 36 months following publication.
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