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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  
 
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.

 
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