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.: PACTR201810739290859 Date of Approval: 05/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of IV Midazolam Premedication on the Recovery of Pediatric Patients after Isoflurane Anesthesia for Cochlear Implant Surgery
Official scientific title Effect of Midazolam Premedication on the Recovery of Pediatric Patients after Isoflurane Anesthesia
Brief summary describing the background and objectives of the trial testing effect of midazolam premedication on recovery of pediaric patients in cochlear implant surgeries
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 Prevention
Anticipated trial start date 10/10/2018
Actual trial start date 10/10/2018
Anticipated date of last follow up 10/01/2019
Actual Last follow-up date 10/01/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group midazolam 0.01 mg/kg of IV midazolam in 2 ml of 0.9% saline , two minutes before induction once only midazolam premedication 30
Control Group saline 0.9% saline two minutes before induction once only saline premedication 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children aged 1-6 years class I, II American Society of Anesthesiologists (ASA) classification mentally disabled children allergy to midazolam patients on medication that could interact with, or affect the pharmacokinetics and pharmacodynamics of midazolam such as clarithromycin, antiepileptics or sedatives. Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 6 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 25/09/2018 AIN shams university research ethics committee
Ethics Committee Address
Street address City Postal code Country
abbasyia cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome this study was performed to investigate the effect of intravenous midazolam premedication on the recovery characteristics from isoflurane anesthesia in pediatric patients undergoing cochlear implant surgery. Time to spontaneous eye opening ,Time to react with the nurse or the parents ,Time to attain full modified Aldrete score ,Time to drinking ,Time to hospital discharge
Secondary Outcome emergence agitation after recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital abbasyia street Cairo 11566 Egypt
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 ashraf nabil abbasya cairo 11566 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mona hosny monamourmar@hotmail.com +201001540563 mohandessein
City Postal code Country Position/Affiliation
cairo 12611 Egypt assistant professor of anesthesia and intensive care medicine
Role Name Email Phone Street address
Public Enquiries ashraf nabil ashraf_nabel@med.asu.edu.eg +201001100613 abbasia
City Postal code Country Position/Affiliation
cairo 11566 Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Scientific Enquiries wail abdelal wailabdelaal64@yahoo.com +201067499156 abbasia
City Postal code Country Position/Affiliation
cairo 11566 Egypt assistant professor of anesthesia and intensive care medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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