| CTRI Number |
CTRI/2026/03/105546 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
OPTIMUM DEXEMEDETOMIDINE DOSAGE FOR INTERSCALENE BLOCK IN ARTHROSCOPIC SHOULDER SURGERY FOR INTRA-OPERATIVE SURGICAL CONDITION AND POST-OPERATIVE ANALGESIA |
|
Scientific Title of Study
|
OPTIMAL DEXEMEDETOMIDINE DOSAGE FOR INTERSCALENE BLOCK IN ARTHROSCOPIC SHOULDER SURGERY FOR INTRA-OPERATIVE SURGICAL CONDITION AND POST-OPERATIVE ANALGESIA |
| 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 Yagya Bikram Basnett |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Operation theater, 6th floor, Department of Anaesthesia, Kasturba Medical College, Attavar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7548028484 |
| Fax |
|
| Email |
yagyabasnett@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil BV |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College |
| Address |
6th floor, Department of Anaesthesia, Kasturba Medical College, Attavar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
sunil.bv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yagya Bikram Basnett |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
6th floor, Department of Anaesthesia, Kasturba Medical College, Attavar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7548028484 |
| Fax |
|
| Email |
yagyabasnett@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Ksaturba Medical College, 203, Lighthouse Hill Road, Hampankatta, MANGALURU |
| Type of Sponsor |
Private medical college |
|
|
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 Yagya Bikram Basnett |
Kasturba Medical College |
6th floor, Department of Anaesthesia, Attavar,Mangaluru
Dakshina Kannada
KARNATAKA |
7548028484
yagyabasnett@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring any arthroscopic shoulder surgery. |
|
| ExclusionCriteria |
| Details |
1) Patients unwilling to participate in the study.
2) Patients with contraindications to Regional Anaesthesia.
3) Patients with known allergy to local anaesthetics
4) Patients with American Society of Anaesthesiology (ASA) Grade III or higher
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Surgical field condition scoring .
VAS scoring for post op analgesia
|
Surgical field condition scoring . Intra op
VAS scoring for post op analgesia. 6 hours post op
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Systolic & Diastolic Blood Pressure
- Mean Arterial Pressure
- Heart Rate
- Dose of Ephedrine & atropine used
|
Baseline
15 mins
30 mins
1 hour |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2026 |
| 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="2"
Months="6"
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 - NO
|
|
Brief Summary
|
This prospective observational study will be conducted at Kasturba Medical College Hospitals, Mangalore (KMC Attavar, UMC Ambedkar Circle, and Govt Wenlock Hospital) to determine the optimal dose of dexmedetomidine as an adjuvant in ultrasound-guided interscalene brachial plexus block for patients undergoing arthroscopic shoulder surgery under general anaesthesia.
Adult patients aged 18–60 years, ASA I–II, scheduled for arthroscopic shoulder surgery will be included. Participants will be grouped based on the dose of dexmedetomidine administered in the interscalene block:
- Group A: 0.5 mcg/kg dexmedetomidine
- Group B: 1 mcg/kg dexmedetomidine
The primary outcomes will be intra-operative surgical field condition score and post-operative analgesia assessed using VAS score (including time to first rescue analgesia). Secondary outcomes include hemodynamic parameters (HR, SBP, DBP, MAP) and the requirement of vasopressors (ephedrine/mephentermine) and atropine.
The study aims to identify the dose providing better surgical field conditions, hemodynamic stability, and prolonged post-operative analgesia, thereby improving perioperative outcomes in shoulder arthroscopy.
|