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CTRI Number  CTRI/2026/02/104490 [Registered on: 23/02/2026] Trial Registered Prospectively
Last Modified On: 22/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Administration of Intravenous fluids pre operatively with the use of an ultrasound to know the volume status in patients undergoing orthopaedic lower limb surgeries under spinal anaesthesia to prevent post spinal anaesthesia hypotension 
Scientific Title of Study   INFERIOR VENA CAVA COLLAPSIBILITY INDEX (IVC-CI) GUIDED FLUID THERAPY: COMPARATIVE EFFICACY OF TWO DIFFERENT CUTOFF VALUES IN PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION IN PATIENTS UNDERGOING ORTHOPAEDIC LOWER LIMB 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  SHAIK MOINUDDIN 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS Gorakhpur 
Address  OT COMPLEX , Department of Anaesthesiology, Pain Medicicne and Critical care, ALL INDIA INSTITUTE OF MEDICAL SCIENCES , GORAKHPUR , UTTAR PRADESH.

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9059345204  
Fax    
Email  shaikmoinuddin7890@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ganesh Ramaji Nimje 
Designation  Associate Professor 
Affiliation  AIIMS Gorakhpur 
Address  AIIMS GORAKHPUR

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9503332784  
Fax    
Email  ganesh.nimje8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shaik Moinuddin 
Designation  Junior Resident 
Affiliation  AIIMS Gorakhpur 
Address  AIIMS GORAKHPUR

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9059345204  
Fax    
Email  shaikmoinuddin7890@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Gorakhpur 
Address  Department of Anesthesia, OT Complex, AIIMS Gorakhpur, India 
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 Shaik Moinuddin  ALL INIDA INSTITUTE OF MEDICAL SCIENCES , GORAKHPUR  OT COMPLEX, Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS Gorakhpur.
Gorakhpur
UTTAR PRADESH 		 9059345204

shaikmoinuddin7890@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, AIIMS Gorakhpur, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL GROUP  Pre operative IVCCI is measured and noted . Patient will recieve standard fluid therapy of 10 ml per kg as per the standard institutional protocol 
Intervention  GROUP CI 35  Measure IVCCI preoperatively 1.If IVC CI is less than 35 percent : Do not administer preload fluid 2.If IVC CI is greater than 35 percent : administer 5 ml per kg crystalloid over 15 mins 3. Repeat measurement and fluid bolus every 15 minutes until IVC CI less than 35 percent, up to a maximum of 4 boluses (total of 20 mL per kg). 4. Stop when IVC CI falls to less than 35 percent or after maximum volume is administered.  
Intervention  GROUP CI 45  Measure IVCCI preoperatively 1.If IVC CI is less than 45 percent : Do not administer preload fluid 2.If IVC CI is greater than 45 percent : administer 5 ml per kg crystalloid over 15 mins 3. Repeat measurement and fluid bolus every 15 minutes until IVC CI less than 45 percent, up to a maximum of 4 boluses (total of 20 mL per kg). 4. Stop when IVC CI falls to less than 45 percent or after maximum volume is administered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age between 18 and 65 years.
2.ASA Physical Status classification I or II.
3. Scheduled for elective lower limb orthopedic surgery that is anticipated to require spinal anesthesia and last less than 3 hours.
4. Able to breathe spontaneously and cooperate fully with the ultrasound measurement protocol
 
 
ExclusionCriteria 
Details  1.Contraindications to spinal anesthesia (for example coagulopathy, infection at the puncture site)
2. Pregnancy or lactation
3. Patient’s refusal to participate in study
4. Patients whose IVCCI could not be assessed (poor visibility of IVC, non-co-operative patients.
 
 
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 
Incidence of post-spinal anaesthesia hypotension (PSAH), defined as fall in Mean Arterial Pressure (MAP) less than 65 mmHg or a decrease of Mean Arterial Pressure (MAP) greater than 20 percent from baseline occurring within 30 mins of spinal anaesthesia.
 		 Base line, every 2 minutes post spinal anaesthesia for 30 minutes, followed by every 5 minutes till the completion of surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
Total Fluid Volume: The cumulative volume of Ringer’s Lactate administered from the start of the pre-spinal intervention up to the end of the surgical procedure.
 		 1.Before spinal anaesthesisa
2.Total fluid volume at the end of surgery 
Vasopressor Requirement: The total cumulative dose of rescue vasopressors like mephentermine administered or need of nor-adrenaline during the intraoperative period.
 		 Intra operative period post induction by spinal anaesthesia 
Severity of PSAH: Incidence of severe hypotension, defined as Mean Arterial Pressure (MAP) falling below 60 mmHg for a duration exceeding 5 minutes.
 		 Intra operative period post induction by spinal anaesthesia 
Incidence of bradycardia - heart rate less than 50 bpm.
Incidence of other adverse events like nausea, vomiting, headache, hypertension.
 		 Intra operative period post induction by spinal anaesthesia 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
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)   17/03/2026 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Post spinal Anesthesia hypotension is one of the common complications encountered after sub arachnoid block.  Preloading with crystalloid fluid is a common practice to prevent post spinal anesthesia hypotension but it carries risk of fluid overload particularly in elderly and cardiac patients  . Hence there is a need for Goal Directed Fluid Therapy to specifically target patients who are fluid responsive . Inferior vena cava collapsibility index is one of the proxy marker to assess the fluid status of the patients. In this study we are going to compare two cut off values of IVCCI for fluid therapy that is 35 percent , which is more sensitive and 45 percent , which is more specific . After the conclusion of the study , we will be able to determine which  cut off value is better indicator for goal directed fluid therapy to prevent post  spinal anesthesia hypotension. 
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