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CTRI Number  CTRI/2022/06/043360 [Registered on: 20/06/2022] Trial Registered Prospectively
Last Modified On: 17/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of Ropivacaine heavy and Bupivacaine heavy in hypertensive patients undergoing surgery under spinal anaesthesia 
Scientific Title of Study   A comparative study of spinal anaesthesia with hyperbaric Ropivacaine 0.75% and hyperbaric Bupivacaine 0.5% in hypertensive patients undergoing lower abdominal surgery and lower limb surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akrity Singh 
Designation  Assistant Professor(Anaesthesia) 
Affiliation  IGIMS 
Address  Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Patna
BIHAR
800014
India 
Phone  9431664293  
Fax    
Email  drakrity_s@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Akrity Singh 
Designation  Assistant Professor(Anaesthesia) 
Affiliation  IGIMS 
Address  Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Patna
BIHAR
800014
India 
Phone  9431664293  
Fax    
Email  drakrity_s@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Akrity Singh 
Designation  Assistant Professor(Anaesthesia) 
Affiliation  IGIMS 
Address  Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Patna
BIHAR
800014
India 
Phone  9431664293  
Fax    
Email  drakrity_s@yahoo.co.in  
 
Source of Monetary or Material Support  
IGIMS 
 
Primary Sponsor  
Name  IGIMS 
Address  Department of trauma and emergency, IGIMS, Sheikhpura , Patna 
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 
Akrity Singh  IGIMS  Department of trauma and emergency, IGIMS, Sheikhpura , Patna
Patna
BIHAR 		 9431664293

drakrity_s@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, IGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I131||Hypertensive heart and chronic kidney disease without heart failure, (2) ICD-10 Condition: I131||Hypertensive heart and chronic kidney disease without heart failure, (3) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, (4) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperbaric Ropivacaine 0.75% and hyperbaric Bupivacaine0.5%   Spinal anaesthesia with hyperbaric 0.75%Ropivacaine and 0.5% bupivacaine in patients with controlled hypertension undergoing lower limb and lower abdominalsurgery intraoperatively upto 1 hr(60min). 
Intervention  spinal anaesthesia  comparison of spinal anaesthesia with hyperbaric Ropivacaine 0.75% and Bupivacaine 0.5% in patients with controlled hypertension undergoing lower abdominal and lower limb surgery intraoperatively up to 1 hr(60min). 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  hypertensive patients, controlled blood pressure both male and female of age group 25- 70 years undergoing surgery under spinal anaesthesia . 
 
ExclusionCriteria 
Details  1. Patient refusal for procedure.
2. ASA grade > III, IV
3. Emergency Surgery
4. Immunocompromised patients
5. All contraindications for Regional
anaesthesia
1. Those with bleeding disorders and local sepsis.
2. Those on anticoagulant and antiplatelet agent.
3. Those allergic to amide anaesthetics.
 
 
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 
Heart rate, Blood pressure, mean arterial pressure recordings  1min, 3min, 5min, 10min,15min,30min, 45min, 60 min intraoperative and postoperative period. 
 
Secondary Outcome  
Outcome  TimePoints 
modified bromage score for motor block assessment, global patient satisfaction scale, and patient comfort score   in the post operative period upto 3-4 hrs 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   21/06/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   we aimed to study the effectiveness of Ropivacine 0.75% and Bupivacaine 0.5% in patients with controlled hypertension undergoing surgery under spinal anaesthesia . The aim to study and evaluate the onset and duration of motor and sensory blockade of Ropivacaine 0.75% and Bupivacaine 0.5% and also the hemodynamic stability of patients and post operative analgesia. 
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