| 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
|
|
|
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
|
|
|
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 anaesthesiologists. Post 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. |