| CTRI Number |
CTRI/2019/01/017274 [Registered on: 25/01/2019] Trial Registered Prospectively |
| Last Modified On: |
17/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Examination of children with glaucoma using a new modality for sedation |
|
Scientific Title of Study
|
Evaluation of Intranasal Dexmedetomidine as a sedative agent for examination of children with pediatric glaucoma without inhalational anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Adavanced Eye Centre, Postgraduate Institute of Medical Education & Research |
| Address |
Room No 116, Advanced Eye Centre,
Postgraduate Institute of Medical Education and Research.
Sector 12
Chandigarh
CHANDIGARH
134109
India |
| Phone |
09814813207 |
| Fax |
01722756112 |
| Email |
sushmita_kaushik@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Advanced Eye Centre, Postgraduate Institute of Medical Education & Research |
| Address |
Room No 116, Advanced Eye Centre
Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09814813207 |
| Fax |
0172-2756112 |
| Email |
sushmita_kaushik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Advanced Eye Centre, Postgraduate Institute of Medical Education & Research |
| Address |
Room No 116,
Advanced Eye Center,
Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09814813207 |
| Fax |
01722756112 |
| Email |
sushmita_kaushik@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh
|
|
|
Primary Sponsor
|
| Name |
Medical Education Cell Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sushmita Kaushik |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Room No 116, Advanced Eye Centre, Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH |
9814813207
01722756112
sushmita_kaushik@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Intranasal Dexmedetomidine 3 ug/kg |
| Intervention |
Dexmedetomidine |
Intranasal Dexmedetomidine 3.5ug/kg administered by an atomizer and examination started after 20 minutes. Maximum time to wait for effect will be 45 minutes. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1) Children with age of 6 months to years requiring Examination under sedation following surgery for pediatric glaucoma.
2) ASA (American Society of Anaesthesiologists) physical status I/II
|
|
| ExclusionCriteria |
| Details |
Cardiorespiratory distress
bradycardia
upper respiratory tract infection
liver disease
seizures
acute medical condition |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of children having successful examination without requiring rescue sedative agent at 30minutes after intranasal dexmedetomidine |
30 minutes after intranasal dexmedetomidine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean time of onset of adequate sedation score (Ramsay’s score)
2.Sedation scores at 10 minutes, 20 minutes and 30 minutes after administration
3.Need of rescue drug if no sedation after 30 minutes
4. Surgeon satisfaction score for completion of procedure (IOP, Corneal diameter, ophthalmoscopy)
5. Discharge time
6. Adverse effects
7. Parents satisfaction
|
Sedation score will be assessed at 10, 20 and 30 minutes after administration of the drug. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2019 |
| Date of Study Completion (India) |
10/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a randomized, prospective, interventional study and will be conducted at Advanced Eye Centre (AEC), Department of Ophthalmology, PGIMER, Chandigarh in collaboration with department of Anaesthesia. Patients will be divided in two groups: Group 3 ug/kg, Group 3.5µg /kg. Children will be given intranasal dexmedetomidine (3/3.5µg/kg) using mucosal atomization device. The time of drug administration will be noted. Ramsay sedation score will be assessed after 10, 20 and 30 min thereafter. When adequate sedative score is achieved, ophthalmic examination will be performed. If adequate sedation in not achieved then rescue sedation will be used and recorded. Patient will be discharged after Revised Alderte Score of 9-10 is reached and the time of recovery will be noted. A note will be made of any complications like bradycardia, arrythmias, desaturation, reduction in respiratory rate will be made. Parents satisfaction scoring will be done as good/ fair/poor.
|