FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072444 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare Fentanyl versus Dexmedetomidine as an additional drug to hyperbaric Ropivacaine for spinal anaesthesia in below umbilical surgeries. 
Scientific Title of Study   Comparison of Fentanyl versus Dexmedetomidine as an adjuvant to hyperbaric Ropivacaine for spinal anaesthesia in infraumbilical surgeries. A randomized controlled trial. 
Trial Acronym  NO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ASHMEET LALLER 
Designation  PG RESIDENT 
Affiliation  MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA DISTRICT HISAR 
Address  ROOM NO.120 DEPARTMENT OF ANAESTHESIA MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA DISTRICT HISAR
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA DISTRICT HISAR
Hisar
HARYANA
125047
India 
Phone  9813365177  
Fax    
Email  Lallerashu11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Sharma 
Designation  Professor 
Affiliation  Maharaja Agrasen Medical College Hisar 
Address  Department of anaesthesia Maharaja Agrasen Medical College Hisar.
Maharaja Agrasen Medical College Hisar
Hisar
HARYANA
125047
India 
Phone  8607672844  
Fax    
Email  dr.jyotiumesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti Sharma 
Designation  Professor 
Affiliation  Maharaja Agrasen Medical College Hisar 
Address  Department of anaesthesia Maharaja Agrasen Medical College Hisar.
Maharaja Agrasen Medical College Hisar

HARYANA
125047
India 
Phone  8607672844  
Fax    
Email  dr.jyotiumesh@gmail.com  
 
Source of Monetary or Material Support  
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA DISTRICT HISAR HARYANA pin code 125047 India 
 
Primary Sponsor  
Name  Dr Ashmeet Laller 
Address  Maharaja Agrasen Medical College Hisar 
Type of Sponsor  Other [Yourself] 
 
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 Ashmeet Laller  Room no, 120 Department of Anaesthesia   Maharaja Agrasen Medical College Agroha Hisar
Hisar
HARYANA 		 9813365177

Lallerashu11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA HISAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  CPT code range 10004 -10021 Total participants 100 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl,Dexmedetomidine,hyperbaric Ropivacaine for spinal anaesthesia in infraumbilical surgeries.  Ropivacaine 0.75% (3ml)and Fentanyl 25 mcg (0.5ml) making total volume 3.5ml and Ropivacaine 0.75% (3ml)or Dexmedetomedine 10mcg (0.1ml)+0.4ml normal saline making total volume 3.5ml will be given in spinal anaesthesia 
Intervention  Fentanyl,Dexmedetomidine,hyperbaric Ropivacaine for spinal anaesthesia in infraumbilical surgeries.  Ropivacaine 0.75% (3ml)and Fentanyl 25 mcg (0.5ml) making total volume 3.5ml and Ropivacaine 0.75% (3ml)or Dexmedetomedine 10mcg (0.1ml)+0.4ml normal saline making total volume 3.5ml will be given in spinal anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  AMERICAN SOCIETY OF ANESTHESIOLOGISTS(ASA) PHYSICAL STATUS CLASS 1 AND 2 
 
ExclusionCriteria 
Details  1. Patient’s refusal .
2. Patient having Bleeding disorders .
3. Patient having Neurological disease.
4. Patient having Local skin infections at the site of spinal block.
5. Patient having Severe back deformities.
6. Patient having Raised intracranial pressure
7. Patient having Cardiac and respiratory disease
8. Patient of Morbid obesity
9. Patient having allergy to study drugs
 
 
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 
1. Onset of sensory block: The onset of sensory block at T-10 level will be taken as the time from injection of anesthetic solution to the loss of sensation to pinprick.
2. Duration of sensory block: Duration will be taken as from time of onset to time at which patient feel sensation to pinprick.
3. Onset of motor block: Onset time of motor block will be taken as the time to acquire complete motor block after the intrathecal injection of local anesthetic.
4. Duration of motor block: Total duration will be taken as time to completely recover from the motor block.
 		 Total duration will be taken as time to completely recover from the block 
 
Secondary Outcome  
Outcome  TimePoints 
• Hypotension
• Bradycardia
• Nausea
• Vomiting
• Shivering
 		 Total duration will be taken upto 6 hours. 
 
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)   03/09/2024 
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="4"
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   Comparison of Fentanyl versus Dexmedetomidine as an adjuvant to hyperbaric Ropivacaine for spinal anaesthesia in infraumbilical surgeries. A randomized controlled trial and observe for primary and secondary outcomes. 
Close