| CTRI Number |
CTRI/2023/07/055336 [Registered on: 18/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To understand the effectivesness of the drugs for paediatric emergence delirium after General Anaesthesia by comparison method scores |
|
Scientific Title of Study
|
SINGLE BOLUS OF DEXMEDETOMIDINE VERSUS PROPOFOL FOR TREATMENT OF PEDIATRIC EMERGENCE DELIRIUM FOLLOWING GENERAL ANAESTHESIA- A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monalisha Ganguly |
| Designation |
Anaesthesia Resident |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Anaesthesia and Critical Care
Armed Forces Medical College, Pune 411040
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
9910969305 |
| Fax |
|
| Email |
monagng@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sud |
| Designation |
Assistant Prof |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Anaesthesia and Critical Care
Armed Forces Medical College, Pune 411040
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
8135915070 |
| Fax |
|
| Email |
monagng@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monalisha Ganguly |
| Designation |
Anaesthesia Resident |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Anaesthesia and Critical Care
Armed Forces Medical College, Pune 411040
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
9910969305 |
| Fax |
|
| Email |
monagng@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARMED FORCES MEDICAL COLLEGE , SOUTHERN COMMAND , SOLAPUR ROAD PUNE 411040 MAHARASHTRA |
|
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Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE AFMC PUNE |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE
AFMC PUNE |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| LT COL GUNJAN |
ARMED FORCES MEDICAL COLLEGE PUNE |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE AT CHSC PUNE OPERATION THEATRE NUMBER 10
Pune
MAHARASHTRA |
9612112136
gunjanafmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AFMC PUNE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: N432||Other hydrocele, (3) ICD-10 Condition: F078||Other personality and behavioral disorders due to known physiological condition, (4) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (5) ICD-10 Condition: H660||Acute suppurative otitis media, (6) ICD-10 Condition: H490||Third [oculomotor] nerve palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Assess efficacy of Dexmedetomidine & Propofol in Pediatric Emergence delirium undergoing General Anaesthesia. |
To compare the efficacy of dexmedetomidine(0.5mcg/kg I.V) compared against that of propofol (1mg/kg I.V) post extubation in pediatric emergence delirium at PACU. |
| Comparator Agent |
comparison of efficacy of Dexmedetomidine against Propofol for the treatment of Pediatric Delirium Emergence |
On completion of surgery, LMA/ ET will be removed while the patients were deeply anesthetized & then the patients will be transferred to the PACU once a spontaneous respiratory pattern is observed after extubation or after removal of LMA following general anaesthesia. Thereafter, random number envelope will be opened to assign the patients to either DG or PG group. The patients in DG group will receive, DEXMEDETOMIDINE (0.5 mcg.kg-1) bolus over 2-3sec. whereas those with PG group will receive 1 mg.kg−1 propofol bolus dose. At postanesthetic care unit (PACU), the primary outcome will be the pediatric anesthesia emergence delirium (PAED) score after treatment & the recovery time using Aldrete score, and the secondary outcome will be the adverse events. |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
(a)Patients undergoing major surgeries
(b)Age more than 1year & less than 12 years
(c) ASA Grade I & II |
|
| ExclusionCriteria |
| Details |
(a) Patients on sedatives/hypnotics pre-operatively
(b)Patients with developmental delay
(c)Pre-existing neurological disorders
(d) Altered sensorium, unable to tolerate overnight fasting
(e)History of allergic reactions to used medications
(f)Associated with Psychiatric illness/cardiac illness |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At PACU, recovery time will be determined using ALDRETE Score after administration of either Dexmedetomidine or Propofol post emergence delirium (PAEDS SCORE) |
Recovery time is interval between arrival at PACU to reaching ALDRETE SCORE more than 9.this is in immediate post extubation period when child was being monitored for pediatric emergence delirium for 30min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It includes the adverse events occurs post operatively & post administration of drugs
Laryngospasm
Desaturation
Bradycardia
PONV
Hypotension |
post administration of drug(Dexmedetomidine or propofol) as per the PAEDS SCORE ,patients will be monitored for an hour for any adverse events as mentioned above(secondary outcome) |
|
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Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/08/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The various studies conducted in different set up in which the comparison for the efficacy of Dexmedetomidine & Propofol was established in the treatment of Pediatric Emergence Delirium undergoing General Anaesthesia, concluded that both the drugs decreased the incidence of Emergence Delirium. However, the studies have been inconclusive in determining a better modality in other countries. Therefore, such studies need relevant data & further extrapolation in the Indian subcontinent. |