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CTRI Number  CTRI/2024/10/075534 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Early Intraoperative Administration of drug increasing blood pressure on Organ Dysfunction after abdominal surgery 
Scientific Title of Study   Early Vasopressor Administration And Postoperative Organ Dysfunction In Elective Abdominal Surgery: A Randomized Controlled Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Kumar Anand 
Designation  Additional Professor 
Affiliation  AIIMS,New Delhi 
Address  Room No 5020,5th floor , Department of Anaesthesiology , Pain Medicine and Critical Care,AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9013082271  
Fax    
Email  drrahulkanand@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rahul Kumar Anand 
Designation  Additional Professor 
Affiliation  AIIMS,New Delhi 
Address  Room No 5020,5th floor , Department of Anaesthesiology , Pain Medicine and Critical Care,AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9013082271  
Fax    
Email  drrahulkanand@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Divya N 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room No 5011,5th floor , Department of Anaesthesiology , Pain Medicine and Critical Care,AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9486463472  
Fax    
Email  divy4499@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, Ansari Nagar 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care,AIIMS New Delhi, Ansari Nagar ,New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 
DrRahul Kumar Anand  AIIMS New Delhi  AB8,Department of Anaesthesiology , Pain medicine and Critical Care,8th floor,Ward Block,All India Institute of Medical Sciences New Delhi,Ansari Nagar
South
DELHI 
9013082271

drrahulkanand@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Comittee  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  Early Noradrenaline infusion  The study will follow the standard hospital procedures and protocols for surgery, anaesthesia, and perioperative care. All patients will undergo invasive arterial pressure monitoring, in addition to standard ASA monitoring. undergo standard management under anaesthesia, the only exception being immediate initiation of noradrenaline infusion at 0.1 mcg/kg/min at the onset of hypotension (defined as fall in MAP 20% from baseline or fall to less baseline or Hg). Noradrenaline dose will be titrated to maintain MAP within 20% of baseline.After surgery patient will be shifted toward/ HDU/ ICU depending upon the clinical status of the patient. Management of the postoperative period will be as per standard department protocol.Duration of intervention till the time of surgery  
Comparator Agent  Standard Treatment Protocol  In case of hypotension, the decision to give fluid boluses or vasopressors (either as bolus or as infusion) will depend solely on the clinical judgement of the anaesthesiologist guided by stroke volume variation/ pulse pressure variation (Edward 1000 Volumeview).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults aged 18 to 70 years undergoing elective major open abdominal surgery with general anaesthesia with expected surgical duration of more than 120 minutes 
 
ExclusionCriteria 
Details  1)Patients who decline to give consent.
2)Patients with poorly controlled hypertension
3)K/c/o CAD, CKD, CLD
4)Patients with primary end organ dysfunction.
5)Patients on monoamine oxidase inhibitors
6)Patients who were pregnant or breastfeeding.
7)Patients with phaechromocytoma/paraganglionoma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the difference in severity of organ dysfunction in the first seven postoperative days between the two groups using the mean SOFA score  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in the individual components of the primary outcome  7 days 
Difference in total fluid infused   24 hours 
Difference in intraoperative blood loss  Duration of surgery 
Difference in cumulative fluid balance at Day7  7 days 
Difference in lactate levels lactate level at end of surgery, 24 post-op  at the end of surgery , 24 hours 
P/F ratio at end of surgery and at 24h post op  at the end of surgery , 24 hours 
Difference in 28-day mortality between the groups  28 days 
Difference in unplanned ICU stay between the groups.  28 days 
Difference in length of hospital stay between the groups  Day 28 
Difference in duration of mechanical ventilation  28 days 
Difference in incidence of AKI   28 days 
Difference in organ failure free days (no need for vasopressors, NIV/IMV or RRT)   28 days 
Difference in mean I-FEED score at day 7 and time to GI-2 recovery  7 days 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   28/10/2024 
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="2"
Months="0"
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  

Intraoperative hypotension is common side effect of general anaesthesia. It has a multifactorial aetiology and associates with increased mortality, stroke, cardiac morbidity, acute kidney injury, and delirium. Even mild hypotension is potentially deleterious. As the blood pressure threshold decreases, the risk of injury increases, and appears to occur with a much shorter duration.Maintenance of adequate BP and organ perfusion is, therefore, a key priority in the perioperative period. Current strategies include intravenous (IV) fluids and vasopressors. Norepinephrine, a mixed α1 and β1-adrenergic agonist, offers a favourable pharmacological profile to maintain BP in the perioperative setting. Thus, administration of norepinephrine may provide an effective strategy to safely achieve and maintain BP thresholds and prevent or attenuate hypotension in the intra- and postoperative period.The sequential organ failure assessment (SOFA) score is a simple and objective scoring system that represents degree and progression of dysfunction with a four-point assessment for each of the six organ systems (central nervous system, cardiovascular system, respiratory system, renal system, liver and coagulation). This assessment was initially developed to describe and quantify organ function and has been validated in various clinical situations. An increase in the SOFA score during ICU treatment has also been associated with progressive organ failure and increased mortality in various clinical settings . Perioperative administration of vasoactive drugs may reduce postoperative complications and hospital length of stay in adult patients having major abdominal surgery and length of hospital stay.In this study, We aim to determine the association between the mean SOFA score for 7 days and postoperative outcomes in patients who have early administration of noradrenaline for intraoperative hypotension during major abdominal surgery.

 

 
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