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.: PACTR202308758655839 Date of Approval: 23/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Emergence Agitation after Sevoflurane Anesthesia in Adenotonsillectomy operations: A Placebo-controlled prospective study for evaluation of prophylactic effect of oral premedication
Official scientific title Emergence Agitation after Sevoflurane Anesthesia in Adenotonsillectomy operations: A Placebo-controlled prospective study for evaluation of prophylactic effect of oral premedication
Brief summary describing the background and objectives of the trial Our current study will be carried out on 220 patients ASA I & II, aged 3-10 years old children,who will be scheduled for adenotonsillectomy operations. After obtaining a written informed consent from parents at anesthesia previsit for patients who will be included in our study.The patients will be randomized into four groups to receive different oral premedications 30 minutes before general anesthesia; Group (P): Patients will receive a plain apple-flavored sugary fluid free of drugs (placebo group). Group (M): Patients will receive the sugary fluid containing dissolved midazolam in a dose of 0.5 mg/kg. Group (D) Patients will receive the sugary fluid containing dissolved dexmedetomedine in a dose of 4µg/ kg. Group (G): Patients will receive the sugary fluid containing dissolved gabapentin in a dose of 10 mg/kg. Sevoflurane anesthesia will be administered via face mask O2. Analgesia will be with intravenous fentanyl 1µg/kg under routine monitoring measures for oxygen saturation, heart rate and noninvasive blood pressure. The aim of our present study is to test and compare the effect of oral midazolam, dexmedetomedine, and gabapentine premedication on the incidence of postoperative emergence agitation after sevoflurane general anesthesia for adenotonsillectomy operations.
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 01/09/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date 01/12/2023
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants)
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo Group throughout the whole procedure Patients will receive a plain apple-flavored sugary fluid free of drugs (placebo group). 55 Placebo
Experimental Group midazolam group throught out the whole procedure Patients will receive the sugary fluid containing dissolved midazolam in a dose of 0.5 mg/kg 55
Experimental Group dexmedetomedine group through out the whole procedure Patients will receive the sugary fluid containing dissolved dexmedetomedine in a dose of 4µg/ kg. 55
Experimental Group gabapentin group through out the whole procedure Patients will receive the sugary fluid containing dissolved gabapentin in a dose of 10 mg/kg. 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- ASA I & II, 2- aged 3-10 years old children 3-who will be scheduled for adenotonsillectomy operations 1-ASA II & III 2-any children with congenital anomalies 3- out side the range of current age 4- History of allergy to the medication included in the study 5- Child with cardiac or respiratory diseases Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 10 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 26/06/2023 Scientific Research Ethics Committee Kafrelsheikh university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El Geish street, Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence and severity of EA in PACU will be evaluated by the Pediatric Emergence Delirium (PAED) scale consisted of 5-behavoural items, each was scored from 0 to 4 indicating extremely to not at all and the score is the sum of values for the five items post operative
Secondary Outcome 1- Duration of anaesthesia; defined as duration since induction of anaesthesia till stoppage of inhalational anaesthetic 2- Time till extubation; defined as time since stoppage of inhalational anaesthetic till extubation 3- Time till emergence of anaesthesia; defined as time since extubation till patients’ response by eye opening or purposeful movement in PACU. 4- Level of consciousness after emergence; which will be evaluated using the Ramsay sedation score (RSS) with RSS=1 if patient is anxious and agitated or restless or both; RSS=2 if patient is co-operative, oriented, and calm; RSS=3 if patient is responsive to commands only; RSS=4 if patient is exhibiting brisk response to light glabellar tap or loud auditory stimulus; RSS=5 if patient is exhibiting a sluggish response to light glabellar tap or loud auditory stimulus and RSS=6 if patient is unresponsive. 5- Postoperative pain will be assessed using Children and Infants Postoperative Pain Scale (CHIPPS) score [10] and if CHIPPS pain score was <5, diclophenac will be injected intramuscular in dose of 1 mg/kg and if >5, fentanyl 0.5-1 µg/kg will be injected as a rescue medication in PACU with monitoring oxygen saturation using pulse oximetry from start of operation till the end of operative and postoperatively at Pediatric ICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospitals El geish street , Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Kamal hafez Arafa 12 Tout Angh Amoun street Tanta 3351111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
Secondary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
sherif kamal hafez arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
Amir abuzikary El Sayed 23 Mohb street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries Amir Abuzikary aabozikry@yahoo.com 01016326544 23 Mohb street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in article, after deidentification (text, tables, figures and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
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