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CTRI Number  CTRI/2024/04/066058 [Registered on: 22/04/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the efficacy of fentanyl versus magnesium sulphate as adjuvants with 0.75% hyperbaric ropivacaine in spinal anaesthesia for lower abdominal surgeries 
Scientific Title of Study   Comparision of add on intrathecal fentanyl vs magnesium sulphate to hyperbaric ropivacaine for 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  Dr Kamakshi Garg 
Designation  Professor  
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia, First Floor, Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9814444121  
Fax    
Email  drkamakshigarg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjamjot Singh Suri 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana
Pg Hostel Room no.N27, Dmch ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9888577222  
Fax    
Email  sss.jot@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjamjot Singh Suri 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9888577222  
Fax    
Email  sss.jot@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Ludhiana, Punjab, India PIN 1410001 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India 
Type of Sponsor  Private 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 Kamakshi Garg  Dayanand Medcial College and Hospital  Department of Anaesthesia, Dayanand Medical College and Hospital, Tagore Nagar Civil lines Ludhiana 141001
Ludhiana
PUNJAB 		 9814444121

drkamakshigarg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical committee, Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  25mcg Fentanyl+ 2.5ml of 0.5% Hyperbaric Ropivacainbne  Patients in group F will receive single shot of 2.5ml of 0.75% hyperbaric ropivacaine with 25mcg fentanyl intrathecally before surgical procedure 
Comparator Agent  Magnesium Sulphate 100 mg+ 2.5ml of hyperbaric ropivacaine+ 0.3ml of distilled water  Patients in group M will recieve a single shot of 2.5ml 0.75% Hyperbaric ropivacaine with 100mcg magnesium sulfate and 0.3ml distilled water intrathecally 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  85.00 Day(s)
Gender  Male 
Details  1. American Society of Anaesthesiologists physical status grade I & II
2. Age 18 years and above
3. Either gender 
 
ExclusionCriteria 
Details  1. Patient not giving consent for spinal anaesthesia
2. Patients who are allergic to the drugs being used
3. Patients in whom spinal anaesthesia is contraindicated 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset and duration of motor and sensory block  Onset and duration of motor and sensory block 
 
Secondary Outcome  
Outcome  TimePoints 
hedodynamics
efficacy of the drugs 		 intraoperative baseline, every minute for 5 minutes & then every 15 minutes for 90 minutes. Postoperatively every hour for 6 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) 23/07/2024 
Date of First Enrollment (Global)  24/04/2024 
Date of Study Completion (Global) 30/07/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Spinal anaesthesia is commonly used for infra-umbilical procedures. Ropivacaine is a newer amide local anaesthetic agent that has less cardiotoxicity than the commonly used bupivacaine. Adjuvants further help lower the dose of local anaesthetic agents. Opioids, Magnesium Sulphate, and Ketamine are some adjuvants used to decrease the dose of local anaesthetic agents in the sub-arachnoid block. A prospective, double-blinded randomized study will be conducted on 60 adults patients, ASA - l to ll undergoing lower abdominal surgeries under subarachnoid block in which they will be randomly allocated to ethier group F which will receive 2.5ml of 0.75% Hyperbaric ropivacaine with 25mcg fentanyl or to group M which will receive 2.5ml of 0.75% hyperbaric ropivacaine, 100mg magnesium sulphate, o.3ml distilled water 
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