| CTRI Number |
CTRI/2026/04/108802 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to See How Different Amounts of Dexmedetomidine Improve Spinal Anesthesia for Lower Abdominal Operations |
|
Scientific Title of Study
|
A Study to Observe Effect of Different Doses of Dexmedetomidine as an Adjuvant to Hyperbaric Bupivacaine for Spinal Anaesthesia in Patients undergoing Lower Abdominal Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krimi Patel |
| Designation |
Resident Doctor |
| Affiliation |
GCS Medical College Hospital Research Centre Ahmedabad |
| Address |
Department of Anaesthesia GCS Medical College Hospital and Research centre near Chamunda bridge Ahmedabad Gujarat 380025 India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9924758844 |
| Fax |
|
| Email |
krimipatel1304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asmita Chaudhary |
| Designation |
Professor |
| Affiliation |
GCS Medical College Hospital Research Centre Ahmedabad |
| Address |
Dapartment of Anaesthesia GCS Medical College Hospital and Research Centre near Chamunda bridge Ahmedabad Gujarat 380025 India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9879006601 |
| Fax |
|
| Email |
asmivip@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Krimi Patel |
| Designation |
Resident, Department of Anaesthesia |
| Affiliation |
GCS Medical College Hospital Research Centre Ahmedabad |
| Address |
Department of Anaesthesia GCS Medical College Hospital and Researh Centre near Chamunda bridge Ahmedabad Gujarat 380025 India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9924758844 |
| Fax |
|
| Email |
krimipatel1304@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gujarat Cancer Society Hospital, near Chamunda bridge, Ahmedabad, Gujarat 380025, India |
|
|
Primary Sponsor
|
| Name |
Gujarat Cancer Society Medical Hospital And Research Centre Ahmedabad Gujarat |
| Address |
Gujarat Cancer Society Hospital, near Chamunda bridge, Ahmedabad, Gujarat 380025 India |
| 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 Asmita Chaudhary |
Gujarat Cancer Society, Medical College, Hospital And Research Centre |
Room Number 105, Anaesthesia OPD, Anasthesia Department, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
9879006601
asmivip@yahoo.co.in |
|
|
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: N219||Calculus of lower urinary tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine + Dexmedetomidine (10mcg) |
Route of administration intrathecal 10mcg Dexmedetomidine diluted in 0.5ml normal saline+ 0.5% bupivacaine (3ml) with total of 3.5 ml volume |
| Comparator Agent |
Bupivacaine + Dexmedetomidine (5mcg) |
Route of administration intrathecal 5 mcg Dexmedetomidine diluted in 0.5ml normal saline + 0.5% bupivacaine (3ml) with total of 3.5ml volume
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Patients of 18-60 years of either gender
Patients posted for elective lower abdominal surgeries |
|
| ExclusionCriteria |
| Details |
ASA Grade 3 and 4
Patient refusal
Hypersensitivity to study drug
Infection at the site of injection
Presence of bleeding disorder disorder
Severe hypotension, bradycardia, severe aortic/mitral stenosis
Raised intracranial tension
Head injury
Patient receiving other modes of intraoperative analgesia
Pregnant females
Patient with neurological disorder and deficit, spinal cord and peripheral nerve diseases, poliomyelitis, multiple sclerosis
Patient on alpha adrenergic antagonists, Ca channel blockers, angiotensin converting enzyme inhibitors |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
1 hour
2 hour
3 hour
6 hour
9 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulse
Systolic Blood Pressure
Diastolic Blood Pressure
spo2 |
0 min
5 min
10 min
15 min
20 min
25 min
30 min
60 min
90 min
120 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
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="0"
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
|
The study compares the onset, duration and quality of sensory and motor block, haemodynamic stability, sedation levels, and side effects across varying doses of dexmedetomidine to determine the most effective and safe dose. |