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.: PACTR202203663979478 Date of Approval: 16/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevention of emergence delirium after sevoflurane anesthesia in children
Official scientific title Prevention of emergence delirium after sevoflurane anesthesia in children: Dexmedetomidine versus midazolam in caudal block. A prospective randomized double blinded study
Brief summary describing the background and objectives of the trial Postoperative emergence delirium is common in pediatric patients anesthetized with sevoflurane, which carries a lot of complications. We aimed to assess the efficacy and safety of caudal dexmedetomidine versus midazolam when added to bupivacaine as adjuvants for reducing the incidence and severity of emergence delirium in children scheduled for lower abdominal or perineal 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 Supportive care
Anticipated trial start date 01/01/2020
Actual trial start date
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine after induction of general anesthesia 1 ml/Kg of bupivacaine (0.25%) in normal saline 25 Active-Treatment of Control Group
Experimental Group bupivacaine and midazolam after induction of general anesthesia 1 ml/Kg of bupivacaine (0.25%) with 30 µg/Kg of midazolam mixed with normal saline up to 1 ml 25
Experimental Group bupivacaine and dexmedetomidine after induction of general anesthesia 1 ml/Kg of bupivacaine (0.25%) with 1.5 µg/Kg of dexmedetomidine in normal saline up to 1 ml 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
child aged 2-6 years American Society of Anesthesiologists (ASA) physical status I or II undergoing lower abdominal or perineal surgeries under general anesthesia pediatric patients known to have coagulopathies, neurological, neuromuscular, or spinal diseases mental retardation signs of infection at the caudal region history of study drug allergy Preschool Child: 2 Year-5 Year 2 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 29/12/2019 Research Ethics Committee Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Ramsis Street Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the degree of emergence delirium at zero minutes then every 15 minutes and up to 1 hour after admission to the post-anesthesia care unit
Secondary Outcome hemodynamics, pain scoring, dexmedetomidine and fentanyl requirements, and duration of post-anesthesia care unit stay at zero minutes then every 15 minutes and up to 1 hour after admission to the post-anesthesia care unit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Ramsis Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rasha Hassan Ramsis Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Ramsis Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasha Hassan rasha.mahmoud6969@gmail.com +966581342400 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Reham Hashim reham_mustafa@med.asu.edu.eg +201003072065 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Mohamed Ali mohamed_mourad@med.asu.edu.eg +201006512101 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the individual de-identified participants’ data. The datasets generated and/or analyzed during the current study will be available on reasonable request to the corresponding author, beginning 12 months and ending 36 months following publication of the manuscript. Study Protocol Beginning 12 months and ending 36 months following publication of the manuscript. Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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