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CTRI Number  CTRI/2024/05/067545 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 04/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usefulness of balanced salt solution versus ringer lactate on postoperative renal parameters and arterial blood gas analysis in patients with hypertension on angiotensin receptor blockers or angiotensin converting enzyme inhibitors in surgeries under general anaesthesia  
Scientific Title of Study   Evaluation of the intra operative use of balanced salt solution versus lactated ringers solution on postoperative arterial blood gas analysis and renal function indicators in patients with primary hypertension treated with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) in elective surgeries under general anesthesia 
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 Nishanth M 
Designation  Junior resident  
Affiliation  Nizams institute of medical sciences  
Address  Department of Anesthesiology and Intensive care, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 Hyderabad TELANGANA 500082 India

Hyderabad
TELANGANA
500082
India 
Phone  8328306685  
Fax    
Email  nishanthmadigela@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Abhiruchi patki 
Designation  Additional professor 
Affiliation  Nizams institute of medical sciences  
Address  Department of Anesthesiology and Intensive care, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 Hyderabad. TELANGANA 500082 India

Hyderabad
TELANGANA
500082
India 
Phone  9177909339  
Fax    
Email  abhiruchipatki2204@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Nishanth M 
Designation  Junior resident  
Affiliation  Nizams institute of medical sciences  
Address  Department of Anesthesiology and Intensive care, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 Hyderabad TELANGANA 500082 India

Hyderabad
TELANGANA
500082
India 
Phone  8328306685  
Fax    
Email  nishanthmadigela@gmail.com  
 
Source of Monetary or Material Support  
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 
 
Primary Sponsor  
Name  Dr Nishanth M 
Address  Junior resident (MD), Department of Anesthesiology and Intensive care, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 Hyderabad TELANGANA 500082 India.ph.8328306685 nishanthmadigela@gmail.com 
Type of Sponsor  Other [Self] 
 
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 Nishanth M  Nizams Institute of Medical Sciences  Department of Anesthesiology and Intensive care, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, 500082 Hyderabad TELANGANA
Hyderabad
TELANGANA 		 8328306685

nishanthmadigela@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group Plasmalyte  Patients receiving plasmalyte as sole intravenous fluid of choice intra operatively and for 24 hours after extubation  
Intervention  Group Ringers lactate  Patients receiving ringer lactate as sole intravenous fluid of choice intra operatively and for 24 hours after extubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
Age 18-60 years
Both genders
Elective surgeries under general anaesthesia of not more than 240 mins in duration
Known case of essential hypertension since more than 2months on angiotensin convertase inhibitor or angiotensin receptor blocker medication  
 
ExclusionCriteria 
Details  ASA grade 3and 4
Patients on diuretics
Patients on beta blockers
Patients on non-steroidal analgesics
Patients with congestive heart failure
Patients with renal artery stenosis
Patients with atherosclerosis, thrombosclerosis
Patients with excessive preoperative fluid deficit due to gastrointestinal fluid loss  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare serum potassium and eGFR in the immediate postoperative period in both the groups with baseline   Serum potassium and eGFR within 1 hour and after 24 hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare serum pH and standard base excess on arterial blood gas analysis in the immediate postoperative period in both the groups  Serum pH and standard base excess measurement at baseline, within in 1 hour and 24 hours after extubation  
To compare serum lactate levels in the plasmalyte group with those in the Ringer’s Lactate group at different time intervals with baseline   Serum lactate levels within 1 hour and 24 hours after extubation  
To compare postoperative serum chloride levels on arterial blood gas analysis in the immediate postoperative period in both the groups With baseline   Serum chloride levels within in 1 hour and after 24 hours of extubation  
To compare perioperative urine output in both the groups.  24 hours urine output after extubation  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   23/05/2024 
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="0"
Months="6"
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   Antihypertensive medications which act on the Renin-angiotensin system by inhibition of the angiotensin converting enzyme (ACEi) or by blocking the angiotensin-2 receptors (ARB) are very commonly used in management of essential hypertension. As a common protocol, these medications are withheld 24 hours before an elective surgery, primarily to avoid intraoperative hypotensive episodes. Regardless of their preoperative withdrawal one day prior to surgery, these medications are likely to increase the risk of postoperative acute kidney injury. Lactated Ringer’s solution is one of the most  used intravenous fluid inside the operating room. Excess lactate in RL thus, reduces strong ion difference and can potentially cause metabolic acidosis. A rise in lactic acidosis or hyperkalemia can further reduce renal perfusion and increase the possibility of AKI. Balanced salt solutions present as a better alternative in such situations as they are iso-osmolar (294mosm/l) and have a pH of around 7.4. Hence, this study aims to compare the effect of balanced salt solution with lactated ringer’s solution on postoperative serum potassium levels, estimated GFR, serum lactates, serum pH and chloride levels in patients with essential hypertension treated preoperatively with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) posted for elective surgeries under general anaesthesia. 
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