| CTRI Number |
CTRI/2025/04/085209 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of general versus neuraxial anaesthesia on perioperative brain natriuretic peptide levels in patients undergoing lower limb surgery |
|
Scientific Title of Study
|
Comparison of general versus neuraxial anaesthesia on perioperative brain natriuretic peptide levels in patients undergoing lower limb surgery - A prospective observational 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 |
Ankita |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Trauma and Emergency Medicine, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9304812924 |
| Fax |
|
| Email |
ankita.sharma483@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Trauma and Emergency Medicine, AIIMS Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9304812924 |
| Fax |
|
| Email |
ankita.sharma483@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Trauma and Emergency Medicine, AIIMS Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9304812924 |
| Fax |
|
| Email |
ankita.sharma483@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Saket Nagar Bhopal, Madhya Pradesh 462020 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
Saket Nagar Bhopal Madhya Pradesh 462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Harish Kumar |
Department of Anaesthesiology, AIIMS Bhopal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita |
AIIMS Bhopal |
Department of trauma and emergency medicine, AIIMS bhopal
saket nagar, MP, 462020
Bhopal
MADHYA PRADESH |
9304812924
ankita.sharma483@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
patients more than 45 years with known cardiac comorbidities as mentioned in inclusion criteria. |
General anesthesia or spinal anesthesia for patients undergoing lower limb surgery and BNP levels will be compared after the surgery |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients over 45 years of age, which fulfil one or more of the following four criteria undergoing non-cardiac lower limb surgery History of coronary artery disease or/and valvular lesion with EF more than 30 percent, History of peripheral arterial disease, History of stroke OR Any three of seven- Age greater than or equal to 70 years, Undergoing major surgery, History of congestive heart failure, History of transient ischemic attack, Diabetes and currently taking an oral hypoglycaemic agent or insulin, History of Hypertension
|
|
| ExclusionCriteria |
| Details |
Cardiomyopathic lesions with EF less than 30 percent.
Tight stenotic lesions
Severe regurgitant lesions
Fatal arrhythmia eg Ventricular tachycardia
renal impairment Cr greater than 1.2
surgery related problems: operation longer than 3 hours
patient resuscitation with more than 3 litres
blood loss more than 1 liter |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum BNP levels were measured |
Preoperatively one hour before surgery and postoperatively eight hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Monitor changes in hemodynamics in relation to type of anesthesia.
2.Efficiency of BNP in detection for cardiac complications in the form of non-fatal MI, arrhythmias and sudden cardiac death until discharged after at least 72h. |
HR, MAP, SBP, DBP, and SpO2 were measured at pre-operative, at induction, 30 mins, 1 hr, 1hr 30mins, 2hrs, 2hrs 30mins, 3hrs, recovery room, 8 hrs post-operative.
Complications were noted 72 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Risk stratification of patients undergoing non-cardiac surgery is vital to minimise peri-operative adverse cardiac and cardiovascular outcomes. Surgery causes myocardial stress and increases cardiovascular risk and mortality. Cardiac biomarkers appear to be better predictors of myocardial damage across all types of surgical procedures. Amongst those predictors, troponin and brain natriuretic peptide (BNP) are the main biomarkers investigated to date. BNP is mainly synthesised and secreted by myocytes in the left ventricle (LV) as a response to myocytes stretched by pressure overload or volume expansion of the ventricle. The synthesis and secretion of BNP can be induced by mechanical stress, systemic ischemia and hypoxia, neurohumoral factors, and more. It is used as a predictor for diagnosing and predicting the prognosis of various heart diseases. Recent studies have demonstrated that elevated serum BNP levels predict the first cardiovascular events and death in the general population. In addition, it has been reported that BNP measured before major surgery can be used as a predictor of postoperative cardiac complications. This prospective observational case-control study aims to compare the cardiac effects of general and neuraxial anaesthesia in consideration of BNP values in lower limb surgery, the hemodynamic changes between two groups perioperatively, and the frequency of postoperative adverse events. |