| CTRI Number |
CTRI/2025/02/079870 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of two doses of a medication which decreases the occurrence of agitation after surgery in children undergoing throat surgery with or without ear surgery. |
|
Scientific Title of Study
|
Comparison of two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/ adenotonsillectomy with or without myringotomy: A Randomized Controlled Trail. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abishma A M |
| Designation |
Postgraduate registrar |
| Affiliation |
Christian Medical College, Vellore. |
| Address |
Department of Anaesthesia,
Christian Medical College,
Vellore- 632 004,
Tamil Nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
7598871290 |
| Fax |
|
| Email |
abismaaugustin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Williams |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore. |
| Address |
Department of Anesthesia,
Christian Medical College,
Vellore- 632 004,
Tamil Nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
8098899339 |
| Fax |
|
| Email |
williamsaparna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abishma A M |
| Designation |
Postgraduate registrar |
| Affiliation |
Christian Medical College, Vellore. |
| Address |
Department of Anesthesia,
Christian Medical College,
Vellore- 632 004,
Tamil Nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
7598871290 |
| Fax |
|
| Email |
abismaaugustin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Fluid Grant, Christian Medical College, Vellore- 632004, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Institutional Fluid Grant Christian Medical College |
| Address |
Christian Medical College, Vellore- 632004, Tamil Nadu. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abishma A M |
Christian medical college |
Department of Anaesthesia,
Christian Medical College,
Vellore
Vellore
TAMIL NADU |
7598871290
abismaaugustin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine 0.4mcg/kg iv |
Dexmedetomidine 0.4mcg/kg iv single bolus over 10minutes after intubation before the insertion of mouth gag. |
| Comparator Agent |
Dexmedetomidine 1mcg/kg iv |
Dexmedetomidine 1mcg/kg iv single bolus over 10minutes after intubation before the insertion of mouth gag. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2 children between the ages of 2 to 12 years scheduled for tonsillectomy/ adenotonsillectomy with or without myringotomy will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
Children with a known history of allergy to the study drug, neurological, neuromuscular, renal or hepatic diseases, craniofacial abnormalities and cardiac diseases will be excluded. All patients scheduled for DISE (Drug Induced Sleep Endoscopy) will also be excluded. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare two doses of Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy/adenotonsillectomy with or without myringotomy. |
In Post Anaesthesia Care Unit(PACU), the Watcha- scale (Asleep-0, calm-1, crying but can be controlled-2, crying but cannot be controlled-3, agitated and thrashing-4) will be used to record emergence agitation by a blinded anaesthetist every 10 minutes for the first 30 minutes and every 15
minutes for the next 30 minutes after endotracheal tube was removed. watcha scale score will be recorded at 10minutes 20 minutes, 30 minutes, 45minutes and 60minutes in PACU.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the time to wake up, need for rescue analgesic, if needed its dose, the incidence of PONV & duration of stay in the PACU. |
Ramsay Agitation Sedation Scale RASS score assessed at 10,20,30,45,60minutes after endotracheal tube was removed. Fentanyl 1 mcg/kg iv will be given as rescue medication & time at which the first dose given will be noted if the watcha score is more than or equal 2 during 1hr in PACU. The wake-up time extubation to time to eye open & prevalence of PONV at 10,20,30,45,60minutes & duration of stay in PACU will also be recorded once the patient is discharged from PACU.
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Adenotonsillectomy is one of the most common surgeries performed by otorhinolaryngologists in children under general anaesthesia. In addition to nausea, vomiting, severe pain and poor oral intake, emergence delirium after adenotonsillectomy is one of the main reasons for postoperative morbidity, which may delay the discharge, influence the patient ability to return to normal activity, increase the duration of hospital stay and overall medical cost. Emergence delirium causes distress among children, parents and caregivers thereby increasing dissatisfaction towards the quality of care. Postoperative agitation occurs commonly in young children, generally presenting shortly after emergence from general anaesthesia commonly with volatile agents. Studies have found that children can become agitated at any time during their stay in post anaesthesia care unit. Post operative emergence delirium can be associated with several causes including pain, anxiety, physiological compromise and anaesthetic side effect. Emergence delirium in children is frequent but a preventable complication. Many drugs have been used in practice to prevent emergence delirium in children post anaesthesia. One such drug is dexmedetomidine. Dexmedetomidine is a potent selective alpha 2 agonist which has diverse actions providing dose dependent sedation, anxiolysis, analgesia, perioperative sympatholytic action, anaesthetic sparing effects without relevant respiratory compromise. It decreases heart rate, blood pressure and cardiac output in a dose dependent manner with preservation of respiratory function. Because of its favourable sedation characteristics, hemodynamic stability and lack of respiratory depression, dexmedetomidine can be used in paediatric population. It was found that dexmedetomidine offers specific advantages over others drugs that are used for post operative agitation in children after tonsillectomy. Therefore, we plant compare two doses of dexmedetomidine in reduction of emergence delirium after adenotonsillectomy with or without myringotomy in children in this study. |