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.: PACTR202204644214951 Date of Approval: 19/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of nebulized dexmedetomidine as sedative premedication in pediatrics undergoing cochlear implantation
Official scientific title Comparison of the effect of two different doses of nebulized dexmedetomidine as sedative premedication in pediatrics undergoing cochlear implantation
Brief summary describing the background and objectives of the trial Sedation is crucial and challenging part of the management of cochlear implant surgery. Preoperative anxiety is more aggravated in deaf children due to limited communication. Various drugs and routes of administration have been tried with the aim of finding an ideal sedative premedication drug. The sedative effect of dexmedetomidine is concentration dependent as well as inhalation of nebulized dexmedetomidine is associated with high bioavailability. Till now, there is no data for the use of nebulized dexmedetomidine as sedative premedication in deaf children. Therefore, this study compares the efficacy and safety of 2 different doses of nebulized dexmedetomidine to find out the least effective dose in deaf children undergoing cochlear implantation.
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 Treatment: Drugs
Anticipated trial start date 28/04/2021
Actual trial start date 01/05/2021
Anticipated date of last follow up 28/08/2021
Actual Last follow-up date 24/04/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Closed to recruitment,follow-up continuing
Publication URL not available
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 by using procedures such as coin-tossing or dice-rolling 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 Group A 3 µgm /kg Dexmedetomidine diluted in 0.9% saline to form 3ml, 30 min before induction of anesthesia Dexmedetomidine was nebulized for 5 min, 30 minutes before induction of anesthesia 30 minutes before induction of anesthesia, all patients were premedicated by nebulized dexmedetomidine ( 3 µgm /kg) diluted in 0.9% saline to form 3 ml administered via standard hospital jet nebulizers through a mouthpiece using continuous flow of 100% O2 at 6 L/min for 5 minutes with the child in the mother's lap 25 Active-Treatment of Control Group
Experimental Group Group B 4 µgm / kg Dexmedetomidine diluted in 0.9% saline to form 3 ml nebulized 30 min before induction of anesthesia Dexmedetomidine was nebulized for 5 min., 30 min before induction of anesthesia 30 minutes before induction of anesthesia, all patients were premedicated by nebulized dexmedetomidine ( 4 µgm /kg) diluted in 0.9% saline to form 3 ml administered via standard hospital jet nebulizers through a mouthpiece using continuous flow of 100% O2 at 6 L/min for 5 minutes with the child in the mother's lap 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: from 1 to 8 years old sex: male and females American Society of Anesthesiologist physical status (ASA-PS) I-II Children with suspected difficult airway Children with Body Mass Index (BMI) > 30 Children with mental retardation or neurobehavioral disorders History of allergic reactions to Dexmedetomidine Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 8 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 24/04/2021 Faculty of Medicine Ain Shams University Research Committee FMASU REC
Ethics Committee Address
Street address City Postal code Country
Ramsis street, faculty of medicine Ain Shams university, Abbassia, Cairo, Egypt cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate and compare parental separation, 30 minutes after premedication with two different doses of nebulized dexmedetomidine using the parental separation anxiety scales PSAS as follow: 1= easy separation, 2= whimpers, but is easily reassured, not clinging, 3= cries and cannot be easily reassured, but not clinging to parents, and 4= crying and clinging to parents. PSAS scores of 1 and 2 signified calm separation whereas scores of 3 and 4 implied difficult separation. 30 min after premedication with nebulized dexmedetomidine
Secondary Outcome Sedation level was assessed using the Sedation Scale (SS-5). 1= Rarely awake, needs shaking to wake up, 2= Asleep, eyes closed, wake up when lightly touched, 3= Sleepy, but eyes open spontaneously, 4= Awake, and 5= Agitated. The onset of sedation, the minimum time interval necessary to achieve a SS-5 score of 3, and time to Peak sedative effect, the time interval from drug administration to reaching maximum level of sedation, were recorded Sedation level was assessed at the time of start of nebulization as baseline value then every 10 min till parental separation, 30 minutes after premedication
Secondary Outcome Bispectral index (BIS) to measure sedation level. on child admission to operating theater
Secondary Outcome Patients Hemodynamics Heart Rate, Mean Arterial Pressure and peripheral O2 saturation SPO2 Baseline before premedication, min 10, min20 ,min 30 , immediately after induction of anesthesia , minimum and maximum readings throughout surgical procedure
Secondary Outcome Ease of venipuncture (EVP) was graded as poor (uncooperative without success), fair (uncooperative with success), good (minor resistance), or excellent (no reaction at insertion of venous access before induction of anesthesia
Secondary Outcome Quality of surgical field (QSF) assessed by operating surgeon using QSF score as follow 1 = minimal bleeding: not a surgical annoyance, 2 = mild bleeding: but does not affect dissection, 3 = moderate bleeding: slightly compromises dissection, 4 = severe bleeding: significantly compromises dissection, 5 = massive bleeding: prevent dissection. During surgery
Secondary Outcome Recovery time from discontinuation of anesthesia until child opens his or her eyes and become oriented, was recorded in minutes After discontinuation of anesthesia
Secondary Outcome Emergence agitation (EA) was assessed in post anesthesia care unit PACU using the Watcha scale as follow 0= Asleep, 1= Calm, 2= Crying, but can be consoled, 3= Crying, but cannot be consoled, 4= Agitated and thrashing around. Score more than 2 indicates the presence of EA on admission to PACU
Secondary Outcome Adverse events such as hypotension (MABP reduction greater than 20% from baseline value) requiring fluid bolus administration, bradycardia (defined as HR< 100 bpm in patients 1-3 years old and <60 beats/min in patients 3-8 years old) requiring atropine administration, hypoxemia (defined as SpO2 <90%), the occurrence of postoperative shivering and postoperative nausea and vomiting were noted. perioperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University hospitals Abbassia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rania Magdi ali Noura M. Youssri Mahmoud Faculty of medicine Ain shams university Ramsis street Abbassia Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rania Magdi Ali Faculty of medicine Ain shams university, Ramsis Street, Abbassia Cairo Egypt 11591 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Noura M. Youssri Mahmoud Faculty of medicine, Ain Shams university, Ramsis street , Abbassia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Magdi Ali rania.magdiali@Yahoomail.com +201001230545 Faculty of medicine Ain Shams university, Ramsis street, Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Professor of Anesthesia intensive care and pain management faculty of medicine Ain Shams university
Role Name Email Phone Street address
Public Enquiries Rania Magdi Ali rania.magdiali@yahoo.com +201001230545 Faculty of medicine, Ain Shams university, Ramsis street ,Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Professor of Anesthesia intensive care and Pain management faculty of medicine Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Fathy Tash Viced.research@med.asu.edu.eg +226857539 Faculty of medicine Ain Shams university Ramsis street Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor Faculty of medicine Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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