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.: PACTR201710002426237 Date of Approval: 14/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TIVA in pediatric
Official scientific title Recovery with Propofol Anesthesia in Children Undergoing Cleft Palate Repair; Comparison with Svoflurane Anesthesia
Brief summary describing the background and objectives of the trial Inhalational anesthesia has been the mainstay in pediatric anesthesia till recent times. But with the advances in understanding of pharmacology and availability of new fast-acting drugs and the modern infusion pumps, total intravenous anesthesia (TIVA) has become an attractive option in the administration of general anesthesia in children. The arguments for and against TIVA when compared with volatile anesthesia are still a matter of debate . The advantages of propofol over conventional volatile anaesthetic agents used in children are quicker recovery with less distress behaviour , reduced airway reactivity and improved post-operative ciliary function , and reduced nausea and vomiting . In this study, we aimed to compare infusion of propofol vs. inhalational based anesthesia for pediatrics undergoing cleft palate repair in emergence characteristics and respiratory adverse events.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied clefet palate,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2017
Actual trial start date 30/06/2017
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date 01/05/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group inhalatonal aneasthesia General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), fentanyl 1 µg/kg and cisatracurium 0.15 mg/kg i.v and maintenance of aneasthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% from induction of aneasthesia till end of surgery General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), fentanyl 1 µg/kg and cisatracurium 0.15 mg/kg i.v and maintenance of aneasthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC, and cisatracurium 3ug/kg/hr 40 Active-Treatment of Control Group
Experimental Group TIVA group General anesthesia will be induced with propofol 2.5 mg/kg, fentanyl 1 µg/kg and cisatracurium 0.15 mg/kg i.v and 0.1 mg/kg of lidocaine.Maintenance of aneasthesia by a continuous infusion of propofo from induction of aneasthesa till end of surgery General anesthesia will be induced with propofol 2.5 mg/kg, fentanyl 1 µg/kg and cisatracurium 0.15 mg/kg i.v and 0.1 mg/kg of lidocaine added to prevent propofol injection pain. The children will be intubated with tracheal tubes. Maintenance of aneasthesia by a continuous infusion of propofol 9 mg/kg/h and cisatracurium 3ug/kg/hr by two syringe drivers will be started immediately after loading d 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
80 children, ASA I &II, age 6 months to 1 year, from both sex scheduled to undergoing cleft palate repair surgery. ¿ Children with known severe cardiovascular disease, cerebral, hepatic illness. ¿ Children with URTI; having purulent nasal discharge, fever, or with cough and lower respiratory tract infection (LRTI). ¿ Patients with renal dysfunction or neuromuscular disease. 6 Month(s) 1 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 24/05/2017 quality assurance unt
Ethics Committee Address
Street address City Postal code Country
1, algeish st, tanta,algharbia governate, egypt tanta Egypt
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 24/05/2017 ¿ research ethics committee, quality assurance unit¿ research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
1, algeish st, tanta,algharbia governate, egypt tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome smooth recovery without occurance of any complication as heamodynamic instability or agitation. from extubation till discharge from PACU
Secondary Outcome Perioperative laryngeal spasm and bronchospasm from extubation till discharge from PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta pediatic surgery dpartement el bahr sreet- tanta- elgharbia tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amany Faheem Abd El Salam Omara el estad - tanta -elghabia tanta 31511 Egypt
Ahmed Mohammed Fetouh Abdelhamed el gendy mosque st ,tanta,algharbia governate, egypt tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed fetoh ahmed.abdelrahman@med.tanta.edu.eg 01224778144 elghendy sreet- tanta- elgharbia
City Postal code Country Position/Affiliation
tanta 31511 Egypt doctor
Role Name Email Phone Street address
Public Enquiries nada Faheem Abd El Salam Omara Dr.nada.emera@gmail.com 01118342012 12 nor l din st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohammed Fetouh Abdelhamed Ahmed.abdelrahman@med.tanta.edu.eg 0122477814 5 el_Gendy street, Tanta, Egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 01155338808 moheb street, Tanta, Egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt doctor
REPORTING
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