| CTRI Number |
CTRI/2021/02/031258 [Registered on: 12/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effective dose of intranasal dexmedetomidine for struggle free induction of anaesthesia in children with retinoblastoma undergoing examination under anaesthesia |
|
Scientific Title of Study
|
: Median effective dose of intranasal dexmedetomidine for satisfactory mask induction in children undergoing examination under anaesthesia for retinoblastoma- an up and down sequential allocation study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Subramanian |
| Designation |
consultant anaesthesiologist |
| Affiliation |
Narayana Nethralaya |
| Address |
Department of Ophthalmic Anaesthesia, Room No 105, OT complex , first floor, Narayana nethralaya, NN-2, NH health city ,Narayana Nethralaya,
#258/A, Bommasandra Industrial Area, Hosur road, Bangalore Room No 105, OT, first floor, Narayana nethralaya, NN-2, NH health city , Bangalore 560099 Bangalore KARNATAKA 560099 India |
| Phone |
|
| Fax |
|
| Email |
drshalinisubramanian@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shalini Subramanian |
| Designation |
consultant anaesthesiologist |
| Affiliation |
Narayana nethralaya |
| Address |
Department of Ophthalmic Anaesthesia, Room no 105, first floor, Otr complex, Narayana Nethralaya, NN-2, NH health city,
#258/A, Bommasandra Industrial Area, Hosur road, Bangalore NN-2, NH health city,
#258/A, Bommasandra Industrial Area, Hosur road, Bangalore 560099 Bangalore KARNATAKA 560099 India |
| Phone |
|
| Fax |
|
| Email |
drshalinisubramanian@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shalini Subramanian |
| Designation |
consultant anaesthesiologist |
| Affiliation |
Narayana nethralaya |
| Address |
Department of Ophthalmic Anaesthesia, Room no 105, first floor, OT complex, Narayana Nethralaya, NN-2, NH health city,
#258/A, Bommasandra Industrial Area, Hosur road, Bangalore NN-2, NH health city,
#258/A, Bommasandra Industrial Area, Hosur road, Bangalore 560099 Bangalore KARNATAKA 560099 India |
| Phone |
|
| Fax |
|
| Email |
drshalinisubramanian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Nethralaya,
NN-2, NH health city, #258, Bommasandra industrial area , Hosur road, Bangalore 560099 |
|
|
Primary Sponsor
|
| Name |
Narayana Nethralaya |
| Address |
Narayana Nethralaya, Bommasandra Industrial Area, Hosur Road, Bangalore |
| Type of Sponsor |
Private hospital/clinic |
|
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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 |
| DrShalini Subramanian |
Narayana Nethralaya |
OT complex, First floor,Narayana Nethralaya, NN-2, NH health city,
Bommasandra Industrial area,Hosur road, Bangalore 560099 Bangalore KARNATAKA |
7406610222
drshalinisubramanian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Nethralaya EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C692||Malignant neoplasm of retina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine |
Dixon up and down methodology is a sequential allocation method to determine the median effective dose of a drug to achieve a selected end point. a first dose is given to the first patient, and the next doses are given according to the following rule: if the subject responds positively, the dose is decreased one step for the next subject and, conversely, if the subject does not respond, the dose is increased one step.The first child will be administered 1mcg/kg dose of intranasal dexmedetomedine. Each subsequent child will receive IN dexmedetomidine with interval of 0.2 µg/kg depending upon the response in the previous patient. The dose is decreased by 0.2 µg/kg in the next child if mask acceptance is satisfactory. If unsatisfactory, the dose is augmented by 0.2 µg/kg in the next child. |
| Comparator Agent |
N/A |
N/A |
|
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Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
40 ASA I-III children with known or suspected retinoblastoma aged 1-60 months undergoing EUA ± focal therapy |
|
| ExclusionCriteria |
| Details |
The exclusion criteria are lack of parental consent, known allergy to dexmedtomidine, nasal discharge, renal or hepatic dysfunction, any serious systemic diseases |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to determine the 50% effective dose and estimate the 95% effective dose of intranasal dexmedetomidine to achieve satisfactory mask acceptance The secondary outcome is to study intraprocedural hemodynamics, recovery characteristics and parental satisfaction.
|
baseline, 1 min, 5 min, 10 min and every 10 min till end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to study intraprocedural hemodynamics, recovery characteristics and parental satisfaction. |
At baseline,induction, 1 minute, every 5 minutes till the end of the procedure, recovery from anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2021 |
| 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="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not published yet |
|
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
|
Inhalational anaesthetic technique is the usual method to induce
anaesthesia in children without intravenous access. A smooth, struggle free
induction not only provides a pleasant experience for the child and parent but
also avoids behavioral disturbance at emergence and prevents psychological
stress and combativeness due to forceful mask holding. This is particularly
important in children requiring multiple examinations under anaesthesia like
those with retinobalstoma. This study envisages to find the median effective
dose of intranasal dexmedetomidine as a premedication to ensure satisfactory
mask acceptance during inhalation induction. After a pre-anaesthetic assessment
and informed parental consent, 40 children aged 1-60 months undergoing EUA for
RB will be recruited for this study. After ensuring appropriate NPO, the child
will be administered IN dexmedetomidine in the pre-operative waiting area. The
starting dose of dexmedetomidine will be 1µg/kg. The score by Modified
Observer’s Assessment of Agitation/ Sedation scale (MOAA/S) will be noted. The
child will be taken to the operating room for anaesthesia induction. One parent
will accompany the child. Anaesthesia will be induced using a mask and gradual
incremental doses of sevoflurane in oxygen and various parameters including mask
acceptance, time to loss of eyelash reflex and hemodynamic parameters will be
noted. Successful mask acceptance is defined as a calm, co-operative (with or
without reassurance) or asleep child during inhalational induction. An
intravenous line is secured and anaesthesia is maintained using any technique
as deemed appropriate by the attending anaesthesiologist. The details like mode
of maintaining the airway (mask, LMA), use of fentanyl, propofol, need for
focal therapy like LASER, cryotherapy or intravitreal injection and duration of
procedure and anaesthesia are noted. The recovery characteristics like time to
reach modified Aldrete score of 9, and any untoward event like coughing,
laryngospasm, vomiting, desaturation, Bradycardia at induction , maintenance or
recovery will be noted. The parental satisfaction score with regards to the
induction technique as compared to any previous experience will be recorded
prior to discharge of the child from the hospital
The end point of the study is at discharge of the child from the
hospital. The dose of IN dexmedetomidine in the following child will depend on
the mask acceptance in this child. A dose increment of 0.2µg/kg will be done if
the score for mask acceptance is poor and the child is cryful and combative at
induction. A decrement of 0.2µg/kg in dosing will be done for the next child if
the mask acceptance was effective and successful and smooth.
|