| CTRI Number |
CTRI/2025/11/098182 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| 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
|
“Effect of Bolus Versus Low-Dose Infusion Dexmedetomidine on Emergence Agitation in Paediatric Patients Receiving Sevoflurane Anaesthesia.” |
|
Scientific Title of Study
|
COMPARISON OF EFFECT OF DEXMEDETOMIDINE AS BOLUS OR LOW-DOSE INFUSION FOR THE PREVENTION OF EMERGENCE AGITATION UNDER SEVOFLURANE ANAESTHESIA IN PAEDIATRIC PATIENTS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarun shekhar |
| Designation |
Junior Resident |
| Affiliation |
Armed forces medical college |
| Address |
1st floor
Dept of Anaesthesiology and Critical Care
Armed forces medical college
Wanowarie Pune 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9463961635 |
| Fax |
|
| Email |
tarunhayden@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GUNJAN SINGH |
| Designation |
PROFESSOR |
| Affiliation |
Armed forces medical college |
| Address |
1st floor
Dept of Anaesthesiology and Critical Care
Armed forces medical college
Wanowarie Pune 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
09612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surabhi S Raghav |
| Designation |
CLINICAL TUTOR |
| Affiliation |
Armed forces medical college |
| Address |
1st floor
Dept of Anaesthesiology and Critical Care
Armed forces medical college
Wanowarie Pune 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
09538341501 |
| Fax |
|
| Email |
surabhi.raghav10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
tarun shekhar |
| Address |
1st floor
Dept of Anaesthesiology and Critical Care
Armed forces medical college
Wanowarie Pune 411040 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Tarun shekhar |
Armed forces medical college |
1st floor
Dept of Anaesthesiology and Critical Care
Armed forces medical college
Wanowarie Pune 411040
Pune
MAHARASHTRA |
09463961635
tarunhayden@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAFMCPUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
K40-K46 for hernia cases
Meckels diverticulum is Q43.0.
circumcision is Z41.2anorectal malformation repair is Q42.3 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group-I bolus dexmedetomidine 0.4 µg/kg over 10 min after completion of surgery duration varies from( 1 - 3 hours of surgery) |
Group-I will receive bolus dexmedetomidine 0.4 µg/kg over 10 min after completion of surgery(1-3 hours) and HR, mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded before induction (baseline), at induction and every 5 min after induction during the procedure. |
| Comparator Agent |
Group-II will receive a continuous infusion of dexmedetomidine 0.4 µg/kg/h throughout the procedure |
Group-II will receive a continuous infusion of dexmedetomidine 0.4 µg/kg/h throughout the procedure. HR, mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded before induction (baseline), at induction and every 5 min after induction during the procedure. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA classification I-II
2. Age between 2-12 years
3. Undergoing lower abdominal surgery like (Hernia Repair, Orchidopexy, Meckel’s Diverticulectomy, Circumcision, Anorectal malformation repair) with sevoflurane anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. No consent
2. Developmental delay.
3. Congenital airway or cardiac disorders.
4. History of allergy to study medications.
5. Psychological disorders, epilepsy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence and severity of emergence agitation (EA) between bolus and infusion methods of dexmedetomidine administration. |
In PACU, the intensity of pain to be assessed by using a modified Hannallah pain score – an observational pain score (OPS). Moreover, paediatric anaesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) HR, MAP, SpO2 to be measured and recorded on arrival to PACU and 5, 10, 15, 30, 45, 60 min thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of both methods on extubation time (Duration between the termination of anaesthetic gases & the extubation defined as extubation time) & emergence time (refers to the interval from cessation of anaesthetic agents to the patient’s first observable signs of awakening)
To assess the hemodynamic stability in both groups
To evaluate the postoperative sedation, pain scores, & recovery profiles
|
In PACU, the intensity of pain to be assessed by using a modified Hannallah pain score – an observational pain score (OPS). Moreover, paediatric anaesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) HR, MAP, SpO2 to be measured & recorded on arrival to PACU & 5, 10, 15, 30, 45, 60 min thereafter. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
Emergence agitation EA is a common problem seen in children after they recover from sevoflurane anesthesia with reported rates ranging from 10 to 80 percent It is characterized by restlessness crying confusion and uncontrolled body movements during recovery Although it usually settles on its own EA can cause issues such as self injury bleeding accidental removal of intravenous lines and a longer stay in the post anesthesia care unit PACU The exact causes of EA are complex and involve several factors including postoperative pain rapid awakening in an unfamiliar environment anxiety and sometimes low oxygen levels Sevoflurane is a widely used inhalational anesthetic because it allows quick induction smooth maintenance and stable heart function However compared to agents like halothane or propofol it has a higher risk of causing EA To prevent EA different drugs have been tried including propofol midazolam ketamine and alpha two adrenergic agonists such as clonidine and dexmedetomidine Among these dexmedetomidine has shown special promise because of its calming pain relieving and anti anxiety properties It has been proven to reduce both the occurrence of EA and the need for pain relieving opioids However there is still uncertainty about the best dose to use Higher doses of 0 point 5 micrograms per kilogram or more are effective but can cause side effects like slow heart rate low blood pressure and delayed removal of the breathing tube Lower doses between 0 point 2 and 0 point 4 micrograms per kilogram may offer a safer balance between effectiveness and stable vital signs
Previous research has used both single bolus doses and continuous infusions of dexmedetomidine with mixed results A meta analysis has confirmed its benefit in preventing EA though it may slightly delay recovery from anesthesia and PACU discharge Because there is no clear agreement on the most effective dose or method this study aims to compare dexmedetomidine given as a single bolus versus a low dose infusion for preventing emergence agitation in children |