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CTRI Number  CTRI/2025/08/093144 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 16/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Sedation Depth Using Dexmedetomidine and Propofol During Spinal Anaesthesia 
Scientific Title of Study   Correlation of sedation depth assessed by the ramsay sedation scale and bispectral index using intravenous dexmedetomidine or propofol in patients undergoing spinal anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Bhatiya 
Designation  Second Year Anaesthesia Resident 
Affiliation  Government Medical College Baroda 
Address  Department of Anaesthesiology, New Surgical Block, 2nd Floor, SSG Hospital, Vadodara, Gujarat 390001 India

Vadodara
GUJARAT
390001
India 
Phone  9879735561  
Fax    
Email  ashishkr2707@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jyotsana Maliwad 
Designation  Assistant Professor 
Affiliation  Government Medical College Baroda 
Address  Department of Anaesthesiology, New Surgical Block, 2nd Floor, SSG Hospital, Vadodara, Gujarat 390001 India

Vadodara
GUJARAT
390001
India 
Phone  9879541238  
Fax    
Email  dr.mantujr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ashish Bhatiya 
Designation  Second Year Anaesthesia Resident 
Affiliation  Government Medical College Baroda 
Address  Department of Anaesthesiology, New Surgical Block, 2nd Floor, SSG Hospital, Vadodara, Gujarat 390001 India

Vadodara
GUJARAT
390001
India 
Phone  9879735561  
Fax    
Email  ashishkr2707@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, Government Medical College Baroda And SSG Hospital, Vadodara 
 
Primary Sponsor  
Name  GOVERNMENT MEDICAL COLLEGE BARODA 
Address  Medical College, Baroda Anandpura, Vadodara -390001 Gujarat, India -390001 
Type of Sponsor  Government medical college 
 
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 Ashish Bhatiya  SSG HOSPITAL  Gynaecology Operation Theatre, 1st Floor, Old Prasuti Vibhag, SSG Hospital, Vadodara
Vadodara
GUJARAT 		 9879735561

ashishkr2707@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH MEDICAL COLLEGE AND SSG HOSPITAL BARODA  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  INJECTION DEXMEDETOMIDINE IV   Dexmedetomidine group (Group D) received an intravenous (IV) initial loading dose of dexmedetomidine at 0.5 µg/kg over 10 min followed by a maintenance infusion of 0.5 µg/kg/hr titrated to the targeted RSS and BIS score 
Comparator Agent  INJECTION PROPOFOL IV  Propofol group (Group P) received an IV initial loading dose of propofol 1% at 0.5 mg/kg over 10 min followed by a maintenance infusion of 3 mg/kg/h titrated to the targeted RSS and BIS score.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age Group 18 years to 50 years
ASA I and II
 
 
ExclusionCriteria 
Details  Patient refusal
Patient with local infections of back and spine
Patient having vertebral column anomalies
Patient with bleeding disorders
Patient with obstructive sleep apnea
Patient having hypertension morbid obesity severe hepatic renal endocrinal(DM) neurological disorders Psychiatric drug history gastrointestinal and cardiac dysfunction.
History of allergy to drug understudy
Patient with ACE inhibitors alpha 2 adrenergic receptors antagonists beta blockers calcium channel blockers
 
 
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 
Correlation of sedation depth achieved by both IV drugs  Till 90 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic Stability
Adverse effect if any 		 Till 90 mins 
 
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   Phase 4 
Date of First Enrollment (India)   27/08/2025 
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="1"
Months="0"
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  

Our primary aim is To assess the correlation between the Ramsay Sedation Scale (RSS) scores and Bispectral Index (BIS) values in patients sedated with dexmedetomidine or propofol during spinal anaesthesia.

Our secondary aim is To evaluate the hemodynamic changes associated with the use of dexmedetomidine and propofol and To assess the recovory profile and side effects associated with each sedative agent with hemodynamic stability.

60 patient undergoing below umbilical surgery randomly selected according to inclusion and exclusion criteria and randomly allocated in group P (propofol group) and Group D (dexmedetomidine). all patient given sedation according to dosage and sedation depth, hemodynamic stability, patient and surgeon satisfaction assessed,

We propose that, where there is lack of instrumentation and expertise for BIS score assessment, the RSS score could be used to map the level of sedation. We propose that the RSS should be used to monitor depth in all patients requiring sedation under spinal anaesthesia with accuracy similar to that of the BIS.

 
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