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CTRI Number  CTRI/2024/01/061751 [Registered on: 23/01/2024] Trial Registered Prospectively
Last Modified On: 19/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   DEGREE OF PERFUSION AS A PREDICTOR FOR FALL IN BLOOD PRESSURE IN ELDERLY PATIENTS UNDERGOING HERNIA SURGERY UNDER SPINAL ANAESTHESIA  
Scientific Title of Study   PERFUSION INDEX AS A PREDICTOR FOR HYPOTENSION IN ELDERLY PATIENTS UNDERGOING HERNIOPLASTY UNDER SPINAL ANAESTHESIA-AN 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  SREELAKSHMI PV 
Designation  POST GRADUATE TRAINEE  
Affiliation  CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA EMERGENCY BLOCK 4th floor CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32 GORACHAND ROAD BENIAPUKUR, KOLKATA
DEPARTMENT OF ANAESTHESIA EMERGENCY BLOCK 4th floor CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32,GORACHAND ROAD,BENIAPUKUR,KOLKATA,700014,
Kolkata
WEST BENGAL
700014
India 
Phone  9008580064  
Fax    
Email  srilax66@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR.SUDESHNA BHAR KUNDU 
Designation  ASSOCIATE PROFESSOR  
Affiliation  CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA EMERGENCY BLOCK 4th floor CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32 GORACHAND ROAD BENIAPUKUR, KOLKATA
DEPARTMENT OF ANAESTHESIA EMERGENCY BLOCK 4TH FLOOR CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32,GORACHAND ROAD,BENIAPUKUR,KOLKATA,700014,
Kolkata
WEST BENGAL
700014
India 
Phone  8777725424  
Fax    
Email  sudeshna04cmc@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  SREELAKSHMI PV 
Designation  POST GRADUATE TRAINEE  
Affiliation  CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA EMERGENCY BLOCK 4TH FLOOR CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32 GORACHAND ROAD BENIAPUKUR, KOLKATA
DEPARTMENT OF ANAESTHESIA EMERGENCY BLOCK 4TH FLOOR CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32,GORACHAND ROAD,BENIAPUKUR,KOLKATA,700014,
Kolkata
WEST BENGAL
700014
India 
Phone  9008580064  
Fax    
Email  srilax66@gmail.com  
 
Source of Monetary or Material Support  
CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL  
 
Primary Sponsor  
Name  CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL  
Address  CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32,GORACHAND ROAD,BENIAPUKUR,KOLKATA 700014 
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 
SREELAKSHMI PV  CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL   CALCUTTA NATIONAL MEDICAL COLLEGE AND HOSPITAL 32 GORACHAND ROAD ,BENIAPUKUR,KOLKATA 700014
Kolkata
WEST BENGAL 
9008580064

srilax66@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE,CALCUTTA NATIONAL MEDICAL COLLEGE (EC-CNMC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA PHYSICAL STATUS I AND II UNDERGOING ELECTIVE HERNIOPLASTY UNDER SPINAL ANAESTHESIA  
 
ExclusionCriteria 
Details  1) PATIENTS HAVING CONTRAINDICATIONS FOR SPINAL ANAESTHESIA,LIKE LACK OF CONSENT, RAISED INTRACRANIAL TENSION,INFECTION AT LOCAL SITE, SEVERE AORTIC STENOSIS, COAGULOPATHY,CARDIOVASCULAR INSTABILITY
2) PATIENTS WITH KNOWN ALLERGY TO THE DRUGS INJECTION HEAVY BUPIVACAINR AND FENTANYL
3)PATIENTS RECEIVING ANTIHYPERTENSIVE MEDICATIONS OR VASODILATOR AGENTS
4) PATIENTS WITH BMI >30kg/m2
5)PATIENTS HAVING HEIGHT <150 cm
6)PATIENTS ASA PHYSICAL STATUS III OR MORE
7) PATIENTS HAVING MAJOR CARDIOVASCULAR,RESPIRATORY,RENAL,HEPATIC
,NEUROLOGICAL OR ENDOCRINE DISEASES
8)PATIENTS REQUIRING GENERAL ANAESTHESIA  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
CORRELATION BETWEEN BASELINE PERFUSION INDEX AND THE CHANGES IN MEAN ARTERIAL PRESSURE IN THE INTRAOPERATIVE PERIOD   12 months  
 
Secondary Outcome  
Outcome  TimePoints 
1) CORRELATION BETWEEN BASELINE PERFUSION INDEX AND THE CHANGES IN SYSTOLIC BLOOD PRESSURE AND DIASTOLIC BLOOD PRESSURE INTRAOPERATIVELY
2) CORRELATION BETWEEN BASELINE PERFUSION INDEX AND TIME OF REQUIREMENT OF FIRST DOSE OF PHENYLEPHRINE,TOTAL PHENYL EPHRINE REQUIREMENT , TOTAL INTRAVENOUS FLUID REQUIREMENT AND INCIDENCE OF NAUSEA AND VOMITING  
12 months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   29/01/2024 
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="1"
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  

Spinal anaesthesia is one of the commonly used anaesthetic technique in elderly patients. It tends to be safe and simple procedure and also avoid the various complications associated with general anaesthesia. Despite many recent advances, haemodynamic instabilities associated with it is a daily challenge for the anaesthesiologistsPost spinal anaesthesia hypotension occurs due to sympatholysis, leading to loss of tone of venous capacitance vessels and drop in central venous pressure . Hypotension caused by the spinal anaesthesia is proportional to the spinal anaesthesia block height .Elderly age group having a compromised cardiopulmonary system and reduced physiological reserve makes these hemodynamic instabilities more intolerable as they cannot effectively increase the cardiac output .Intra operative hypotension management by infusion of fluids and crystalloids is effective but can lead to fluid overload in this group of patients. Moreover, vasopressors used to combat hypotension can cause tachycardia, hypertension and coronary ischaemia .

The perfusion index (PI) is relatively a new parameter estimating the plusatility of blood in the extremities, calculated using infrared spectrum. It can be easily derived from a pulse oximeter noninvasively. It assesses peripheral perfusion dynamics occurring due to changes in peripheral vascular tone. PI is calculated as the ratio of pulsatile blood flow to non-pulsatile blood in peripheral tissue. The formula for its calculation is as follows 

Perfusion index   = AC÷DC × 100

Where AC is the infrared signal’s pulsating component and is the light absorbed by the pulsatile blood flow in the artery. The normal range of PI is 0.02% (very feeble strength) to 20% (very strong strength ). PI estimates the status of microcirculation which is densely innervated by sympathetic nerves.  Therefore, multiple factors altering the systemic vascular resistance (SVR) can be assessed by this indicator.  The resting SVR can influence incidence and severity of post-spinal hypotension. Value of PI can be used to assess (SVR). Therefore, assuming that vasodilatation reflecting higher baseline PI can been associated with reduction in blood pressure (BP) following spinal anaesthesia. Previous studies regarding the baseline PI and hypotension following spinal anaesthesia have shown positive correlation in parturients undergoing caesarean surgery.. Not much study has done assessing the correlation between the incidence of post spinal hypotension and PI in elderly age group. Therefore, the aim of this study is to find the correlation between baseline perfusion index and incidence of hypotension in elderly patients undergoing hernioplasty under spinal anaesthesia.

 
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