| CTRI Number |
CTRI/2024/05/067484 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of drug combinations Dexmedetomidine and Fentanyl with Midazolam and Fentanyl through intranasal route in children to make them calm and comfortable before surgery |
|
Scientific Title of Study
|
Comparison of premedication with intranasal Dexmedetomidine and Fentanyl combination with Midazolam and Fentanyl combination in children |
| 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 Nishtha Vij |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital, Ansari Nagar, New Delhi, Delhi
South West
DELHI
110029
India |
| Phone |
9718506789 |
| Fax |
|
| Email |
nishthavijd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeetendra Kumar Bajaj |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital, Ansari Nagar, New Delhi, Delhi
South West
DELHI
110029
India |
| Phone |
9810465070 |
| Fax |
|
| Email |
jeetendrabajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Vij |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital, Ansari Nagar, New Delhi, Delhi
DELHI
110029
India |
| Phone |
9718506789 |
| Fax |
|
| Email |
nishthavijd@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital,New Delhi, India -110015 |
|
|
Primary Sponsor
|
| Name |
Dr Nishtha Vij |
| Address |
Safdarjung Hospital, New Delhi, Delhi |
| 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 |
| Dr Nishtha Vij |
VMMC and Safdarjung Hospital |
Department of Anaesthesiology and Intensive Care, ground floor, Mai n OT building Safdarjung Hospital Campus, Ansari Nagar, New Delhi, Delhi
South West
DELHI |
9718506789
nishthavijd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital |
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 |
Fentanyl and Dexmedetomidine |
dose-Fentanyl-2mcg/kg, Dexmedetomidine-1 mcg/kg
frequency-once before surgery
route of administration- Intranasal
total duration of intervention- (30-60)minutes |
| Comparator Agent |
Fentanyl and Midazolam |
dose-Fentanyl-2mcg/kg, Midazolam-0.2mg/kg
frequency-once before surgery
route of administration- Intranasal
total duration of intervention- (30-60)minutes |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age group (2-6) years ASA grade 1 undergoing elective surgery under general anesthesia with supraglottic airway device or endotracheal tube |
|
| ExclusionCriteria |
| Details |
1. Patients with active upper airway disease
2. Patients with known allergy to study drug
3. Patients at risk for airway obstruction
4. Patients with neurodevelopmental delay |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare ease of parental separation in children undergoing elective surgery by premedication with intranasal combinations of Fentanyl and Dexmedetomidine with intranasal Fentanyl and Midazolam. |
Parental separation assessed once at (30-60) minutes post drug intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of:
1. Preoperative sedation using 4 point sedation scale
2. Mask acceptance using mask acceptance scale
3. Post operative analgesia using FLACC Scale
4. Recovery profile |
1.Pre op sedation scale measured once at baseline pre-operatively.
2. Mask acceptance scale measured once at baseline during induction.
3.FLACC Scale measured post operatively at baseline, 15 minutes,30 minutes, 45 minutes, 60 minutes.
4. Recovery profile once post operatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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 Yet Recruiting |
| 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
|
Premedication in children undergoing surgeries plays a pivotal role in alleviating anxiety, promote relaxation and facilitate smooth induction of anaesthesia. Various drugs have been used as premedication out of which Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist has been increasingly used owing to its various benefits. Fentanyl is a synthetic opioid which acts on mu-opioid receptors to produce analgesia. Midazolam is a benzodiazepam that causes sedation , anterograde amnesia, and hypnosis by acting on GABA receptors on CNS. Here we are trying to compare intranasal drug combinations of Fentanyl and Dexmedetomidine with Fentanyl and Midazolam as premedication in children aged 2-6 years undergoing elective surgery under general anaesthesia. The methodology and administration of drug shall be explained in detail with a written well informed consent from the parents. The children shall be divided into two groups of 30 each using block randomisation technique (Group I will receive intranasal Fentanyl 2mcg/kg and Dexmedetomidine 1 mcg/kg and Group II will receive Fentanyl 2mcg/kg and Midazolam 0.2 mg/kg) using mucosal atomising device. Patient will be taken to pre op room and baseline vitals shall be noted, child will be premedicated with allocated drug group and observed for 30-60 minutes , vital parameters and sedation score shall be noted then ease of parental separation shall be noted using appropriate scale. Patient shall be taken to ot, standard anaesthetic protocol shall be followed, sedation score upon arrival and Mask acceptance score using appropriate scale, hemodynamic parameters shall be noted. After neuromuscular reversal, child will be shifted to post operative care unit and sedation score, FLACC Scale for postoperative pain and vital parameters shall be recorded every 15 minutes uptill 1 hour postoperatively. |