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.: PACTR201911530033705 Date of Approval: 07/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prevention of posoperative emergence delerium in children
Official scientific title Effect of single dose dexmedetomidine on the incidence of emergence delirium after sevoflurane based anesthesia in children undergoing strabismus surgery
Brief summary describing the background and objectives of the trial Emergence delirium (ED) is a common and well-recognised problem in children recovering from general anaesthesia.During ED children risk injuring themselves by dislodging intravenous tubing or drains, losing a skin graft, bleeding from the operative site, increasing their pain, and injuring their caregivers. The child’s behavior can be disruptive to the PACU and often requires increased nursing supervision, which strains nursing resources. also,ED may increase the incidence of new-onset postoperative maladaptive behavior changes. The aim of our study is to evaluate the effect of single dose dexmedetomidine on incidence of emergence delirium in preschool children undergoing strabismus surgery under sevoflurane based general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Mental and Behavioural Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/11/2019
Actual trial start date
Anticipated date of last follow up 15/04/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 General anesthesia only An inhalational induction with sevoflurane (5-8%)in an oxygen. Intravenous fentanyl 1µg /kg and atracurium (0.5 mg/kg) duration of the surgery Inhalational induction of anesthesia in area adjacent to the operating room(OR) then on arrival to OR intubation and initiation of mechanical ventilation. Intermittent positive pressure ventilation will be adjusted to deliver a minute volume of 70–80 ml/kg to maintain normocapnea. A total flow rate of 3–4 l/min. After completion of the surgical procedure, neuromuscular block is reversed by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg and tracheal extubation is done after fulfillment of the criteria of extubation. 35 Placebo
Experimental Group dexmedetomedine dexmedetomedine 0.3 µg/kg intravenous dexmedetomedine will be given 10 min before the end of the operation the same induction and maintenance of general anesthesia as the control group but intravenous dexmedetomedine will be given 10 min before the end of the operation. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children aged 3-7 years ASA physical status I and II patients scheduled for strabismus correction surgeries parents' refusal children with preexisting abnormal behavior or psychiatric disorders developmental delay CNS disease e.g. epilepsy children who are anxious to a degree necessitate preoperative sedation un-cooperation of parents with health care providers e.g. abnormal behavior or trouble makers. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 7 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 01/08/2019 Research Ethics Committee Tanta University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
El-Geish st Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome detection of postoperative emergence delirium on arrival to PACU every 10 min until 30 min then at discharge
Secondary Outcome pain score on arrival to PACU every 10 min until 30 min then at discharge
Secondary Outcome Length of PACU stay from arrival to PACU until fullfilment criteria of discharge
Secondary Outcome Parents' satisfaction during PACU stay
Secondary Outcome Recovery time interval from discontinuation of anesthesia and reversal of muscle relaxant until spontaneous eye opening without stimulation
Secondary Outcome Any adverse events after end of the surgery until discharge from PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine El-Geish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mona Raafat El Ghamry Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Mona Raafat El Ghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona Raafat El Ghamry Elgeish st Tanta 31527 Egypt
Amira Mahfouz Elkeblawy Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raafat El Ghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mona El Ghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Amira Elkeblawy Marmoramero999@gmail.com +201148529429 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age , sex, duration of surgery, recovery time, incidence of emergence delirium, parents' satisfaction, length of PACU stay,pain score, and adverse effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year. the IPD will be available for researchers up on e-mail request with reasons for which the data is requested. request will be sent to e-mail of principal investigator drmonagh19802000@gmail.com
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