| CTRI Number |
CTRI/2019/07/020225 [Registered on: 17/07/2019] Trial Registered Prospectively |
| Last Modified On: |
13/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
: Effect of adding adjuvant dexmedetomidine to local anaesthesia for vitreoretinal surgery |
|
Scientific Title of Study
|
: Effect of adding dexmedetomidine to 0.75% ropivacaine in peribulbar block for vitreoretinal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Subramanian |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Narayana nethralaya |
| Address |
Room No 105, OT, 1st floor, Narayana nethralaya NN-2, NH Health city, Bommasandra, Bangalore Bangalore KARNATAKA 560099 India |
| Phone |
7406610222 |
| Fax |
|
| Email |
drshalinisubramanian@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shalini Subramanian |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Narayana nethralaya |
| Address |
Room No 105, OT, First floor Narayana nethralaya, NN-2, NH Health City, Bommasandra, Bangalore Bangalore KARNATAKA 560099 India |
| Phone |
7406610222 |
| Fax |
|
| Email |
drshalinisubramanian@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shalini Subramanian |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Narayana nethralaya |
| Address |
room No 105, OT, First floor, Narayana Nethralaya, NN-2, NH Health City, Bommasandra, Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
7406610222 |
| Fax |
|
| Email |
drshalinisubramanian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Nethralaya NN2, NH Health City, Bommasandra, Bangalore 560099 |
|
|
Primary Sponsor
|
| Name |
Narayana Nethralaya |
| Address |
NN2, NH Health city, Bommasandra, Bangalore 560099 |
| 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 Shalini Subramanian |
Narayana Nethralaya |
NN 2, NH Health City, Bommasandra, Bangalore 560099 Bangalore KARNATAKA |
7406610222
drshalinisubramanian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Nethralaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H338||Other retinal detachments, (2) ICD-10 Condition: H334||Traction detachment of retina, (3) ICD-10 Condition: H356||Retinal hemorrhage, (4) ICD-10 Condition: H330||Retinal detachment with retinal break, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.75% ropivacaine, hyaluronidase, dexmedetomidine 100 µg/ml |
Group D50 (8 ml of 0.75% Ropivacaine+ 0.5 ml Dexmedetomidine[100µg/ml+ hyaluronidase 37.5U/ml] |
| Comparator Agent |
0.75% ropivacaine, hyaluronidase, dexmedetomidine 100 microgram/ml |
Group D25 (8 ml of 0.75% Ropivacaine+ 0.25 ml Dexmedetomidine [100µg/ml] + 0.25 ml normal saline + hyaluronidase 37.5U/ml) |
| Intervention |
0.75% ropivacaine, hyaluronidase, normal saline |
Group R (8 ml of 0.75% Ropivacaine + 0.5 ml normal saline + hyaluronidase 37.5u/ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
100 ASA I-III adult patients aged greater than 18 years, undergoing vitreoretinal surgery under peribulbar block will be included in the study after obtaining a written informed consent. All patients will undergo routine pre-operative evaluation for vitreoretinal surgery. |
|
| ExclusionCriteria |
| Details |
Patients with history of hypersensitivity to the study drugs, significant cardiovascular disease (second [Mobitz II type] or third degree heart block, obstructive sleep apnea, chronic clonidine therapy, coagulopathy, impaired mental status, refusal to use local anaesthestic technique and pregnancy will be excluded from the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the requirement of supplementation of peribulbar block prior to or during the surgery. |
0,1,2,3,4,5,10, 15 min and every 15 min till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. The secondary outcome is the post-operative analgesic requirement. |
1h,2h,6h,24h post op |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/12/2019 |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Peribulbar anaesthesia is widely used in ophthalmic anaesthesia and is a suitable technique for vitreoretinal (VR) surgery. VR surgery is more painful due to the traction on the ocular muscles or sclera, increased intra-ocular pressure due to insertion of gas bubble or secondary to encirclement procedures. Good akinesia is an essential requisite for VR procedures. Longer acting local anaesthetic agents and adjuvants have been used to prolong the duration of anaesthesia, hasten onset of akinesia, reduce LA toxicity and offer greater patient satisfaction. In this study we aim to study the efficacy of adding dexmedetomidine to 0.75% ropivacaine in PBB for VR surgery. The primary outcome is the requirement of supplementation of peribulbar block prior to or during the surgery.The secondary outcome is the pos-operative analgesic requirement. 100 adult patients undergoing VR surgery will be randomized using a computer generated random number table into one of the three groups. The composition of the study drug used for peribulbar anaesthesia in each of the 3 groups is Group R (8 ml of 0.75% Ropivacaine + 0.5 ml normal saline), Group D25 (8 ml of 0.75% Ropivacaine+ 0.25 ml Dexmedetomidine [100µg/ml] + 0.25 ml normal saline) and Group D50 (8 ml of 0.75% Ropivacaine+ 0.5 ml Dexmedetomidine[100µg/ml]). The time to onset of corneal anaesthesia and akinesia as well as the requirement for block supplementation will be recorded. The heart rate, blood pressure, saturation and sedation level will be monitored during the surgery. The duration of surgery and surgeon satiosfaction will be noted at the end of surgery. The pain relief will be assessed at 1h, 2h, 6h and 24 h post-operatively as well as the total analgesic medication used in 24 hours. The expected outcome is superior quality block without additional supplementation and improvement in post-operative analgesia in the dexmedetomidine group. |