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CTRI Number  CTRI/2025/12/098277 [Registered on: 01/12/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to see whether a commonly used sedative medicine dexmedetomidine can safely increase the duration of spinal anaesthesia in patients undergoing lower abdominal surgery 
Scientific Title of Study   Effect of intravenous dexmedetomidine on duration of spinal anaesthesia with hyperbaric bupivacaine in patients undergoing lower abdominal 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  VARSHINI R V 
Designation  Postgraduate Resident 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, A Block, PSG Institute of medical sciences, Avinashi Road, Peelamedu, Coimbatore, Tamilnadu 641 004.

Coimbatore
TAMIL NADU
641004
India 
Phone  9994412828  
Fax    
Email  varshadevi.v@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DHANABAGYAM G 
Designation  Professor 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, A Block, PSG Institute of Medical sciences and research, Avinashi Road, Peelamedu, Coimbatore, Tamilnadu 641 004.

Coimbatore
TAMIL NADU
641004
India 
Phone  99944 44245  
Fax    
Email  red.sparks100@gmail.com  
 
Details of Contact Person
Public Query  
Name  VARSHINI R V 
Designation  Postgraduate Resident 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, A Block, PSG Institute of Medical Sciences and Research, Avinashi Road, Peelamedu, Coimbatore, Tamilnadu 641 004.

Coimbatore
TAMIL NADU
641004
India 
Phone  9994412828  
Fax    
Email  varshadevi.v@gmail.com  
 
Source of Monetary or Material Support  
PSG Institute of Medical Sciences and Research 
 
Primary Sponsor  
Name  VARSHINI R V  
Address  PSG Institute of Medical Sciences and Research, Avinashi road, Peelamedu, Coimbatore, Tamilnadu 641004 
Type of Sponsor  Other [Self] 
 
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 
VARSHINI R V  PSG Institute of Medical Sciences and Research  Department of Anaesthesiology, Operation Theatre Complex, A Block.
Coimbatore
TAMIL NADU 		 9994412828

varshadevi.v@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Intravenous dexmedetomidine 0.5microgram/kg in 100ml normal saline as bolus dose, ten minutes prior to subarachnoid block with Bupivacaine. 
Comparator Agent  Normal saline  100ml of normal saline as bolus dose, ten minutes prior to subarachnoid block with Bupivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients admitted for Elective lower abdominal surgeries under spinal anaesthesia with ASA grades 1 and 2
 
 
ExclusionCriteria 
Details  Patient refusal Contraindications to regional anaesthesia Patients with hepatic and renal impairment Patients taking Beta blockers and steroids 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of sensory block motor block and analgesia in spinal anaesthesia  Intraoperative period and postoperative period until full recovery of sensory and motor function up to 4 hours post spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters Level of sedation and Adverse effects in spinal anaesthesia  Intraoperative period and postoperative period until full recovery of sensory and motor function up to 4 hours post spinal anaesthesia 
 
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)   03/12/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 double blinded randomized controlled study evaluates the effect of intravenous dexmedetomidine on the duration and quality of spinal anaesthesia with hyperbaric bupivacaine in patients undergoing lower abdominal surgeries. Sixty patients belonging to ASA I and II aged 18 to 60 years are randomly divided into two groups one receiving IV dexmedetomidine and the other normal saline before spinal block. The study compares sensory and motor block duration analgesia hemodynamic stability sedation and adverse effects between two groups. The aim is to determine whether IV dexmedetomidine safely enhances spinal block duration and improves patient comfort and recovery. 
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