| CTRI Number |
CTRI/2024/08/072433 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study of Dexmedetomidine with Ropivacaine in Eye Block for retina surgeries |
|
Scientific Title of Study
|
Prospective randomized comparative study of adjuvant dexmedetomidine to 0.75 percent Ropivacaine with 0.75 percent ropivacaine alone in subtenon blocks for vitreoretinal surgeries |
| 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 Deepa Rakesh Sharma |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, No. 256/14, Kanakapura Main Road, 7th Block Jayanagar
Bangalore
KARNATAKA
560070
India |
| Phone |
08026088000 |
| Fax |
|
| Email |
yathirajdeepa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Rakesh Sharma |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, No. 256/14, Kanakapura Main Road, 7th Block Jayanagar
Bangalore
KARNATAKA
560070
India |
| Phone |
08026088000 |
| Fax |
|
| Email |
yathirajdeepa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Rakesh Sharma |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, No. 256/14, Kanakapura Main Road, 7th Block Jayanagar
Bangalore
KARNATAKA
560070
India |
| Phone |
08026088000 |
| Fax |
|
| Email |
yathirajdeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Super Speciality Eye Hospital, no.256/14, Kanakapura Main Road, 7th block Jayanagar, Bangalore -560 070 |
|
|
Primary Sponsor
|
| Name |
Nethradhama Super Speciality Eye Hospital |
| Address |
No.256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560 070 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Deepa Rakesh Sharma |
Nethradhama Super Speciality Eye Hospital |
Block 1, Second floor, Pre-Operative Room, No. 256/14, Kanakapura Main Road, 7th Block Jayanagar
Bangalore
KARNATAKA |
08026088000
yathirajdeepa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H330||Retinal detachment with retinal break, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.75% Ropivacaine with Dexmedetomidine 20mcg |
Dexmedetomidine 20mcg with 0.75% Ropivacaine 5ml will be given in sub-tenons block prior to retinal surgery. Patient is monitored during surgery and 24hr post-op visit. Duration of study is 3months |
| Intervention |
Plain 0.75% Ropivacaine |
Plain 0.75% Ropivacaine 5ml without Dexmedetomidine is given in sub-tenons block prior to retinal surgery. Patient is monitored during surgery and 24hr post-op visit. Duration of study is 3months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2,3
Satisfactory akinesia following subtenon blocks and predictable surgical time of less than 3hours
|
|
| ExclusionCriteria |
| Details |
Known allergy to dexmedetomidines
Patients with a single eye
History of sleep apnea
Severe Cardiac, respiratory and renal disease
Drowsy on the day of surgery with Ramsay Level of Sedation Scale Score more than 3
Normal sinus bradycardia in ECG, Baseline Hypotension recorded
Dementia
Communication disabilities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of the adjuvant added in sub-tenons block on motor and sensory block. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effect associated with 20mcg Dexmedetomidine as adjuvant in subtenon block |
3 months |
|
|
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)
|
23/08/2024 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Link updated after publications
- For how long will this data be available start date provided 08-11-2024 and end date provided 08-11-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Proposed study will be conducted on 60 patients in the age above 18yrs of either gender with ASA I-III admitted in Nethradhama Super Speciality Eye Hospital, scheduled to undergo elective Vitreoretinal surgery under subtenon blocks patients will be randomly divided into 2groups of 30 each. Group A will receive 0.75% Ropivacaine 5ml, Group B will receive 0.75% Ropivacaine with 20mcg Dexmedetomidine. Parameters to be accessed will include Motor block, sensory block, sedation level post-operative pain, surgeon satisfaction score, patient satisfaction score, concensus sleep diary. Any adverse effect will b e recorded. Follow-up visit on post-op day-1 and one week after surgery. |