| CTRI Number |
CTRI/2025/06/089781 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of pulse oximeter to predict hypotension during surgery |
|
Scientific Title of Study
|
Pleth variability index as a predictor of hypotension following Spinal anaesthesia in infra umbilical surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Haripriya Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
MVJ Medical College |
| Address |
1st floor, OT complex,
Department of Anaesthesiology,
MVJ Medical College, Hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
08970766376 |
| Fax |
|
| Email |
haripri20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Haripriya Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
MVJ Medical College |
| Address |
1st floor, OT complex,
Department of Anaesthesiology,
MVJ Medical College, Hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
08970766376 |
| Fax |
|
| Email |
haripri20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Haripriya Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
MVJ Medical College |
| Address |
1st floor, OT complex,
Department of Anaesthesiology,
MVJ Medical College, Hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
08970766376 |
| Fax |
|
| Email |
haripri20@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVJ Medical College,
Dandupalya, 30th Km Milestone Kolathur P.O, NH75, Hoskote, Karnataka- 562114 |
|
|
Primary Sponsor
|
| Name |
Dr Haripriya |
| Address |
MVJ medical college,
30th mile, Kolathur post, Kolar Highway. Pin 562114 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Haripriya R |
MVJ medical college and research hospital |
1st Floor, OT complex,
MVJ Medical college, 30th mile,Kolathur post, Kolar highway, Bengaluru
Bangalore Rural
KARNATAKA |
08970766376
haripri20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ Medical college and research hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients between 18 and 60 years undergoing infra-umbilical surgeries under spinal anaesthesia.
ASA Physical Status 1 or 2.
Consent to participate in the study.
Patient undergoing infraumbilical surgeries requiring 15 mg of 0.5 per cent of Bupivacaine heavy in subarachnoid block
|
|
| ExclusionCriteria |
| Details |
Patients with pre-existing hypotension or autonomic dysfunction.
History of cardiovascular disease affecting hemodynamic stability.
Use of beta-blockers or other medications affecting heart rate variability.
Obesity, with a BMI greater than 35, it may affect PVI readings.
Peripheral vascular disease.
Poor peripheral perfusion affecting the pulse oximetry signal.
• Patient refusal to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the correlation between preoperative PVI values and the incidence of Spinal anaesthesia induced hypotension. |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Establish a Pleth variability index (PVI) threshold for predicting hypotension.
Assess the sensitivity & specificity of PVI as a predictor
|
One year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2025 |
| 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
|
All patients will undergo general physical examination and routine investigation according to the institutional protocol. Informed consent will be taken. Patients will be kept nil per mouth for 6 hours before surgery. IV line will be secured with an 18 or 20 G intravenous catheter. Infusion of Ringer’s lactate will be started. In the operating room, ASA Standard monitors will be attached. Baseline PVI, PI, HR, BP and SPO2 will be measured in a supine position. Pulse oximetry and PVI values are automatically calculated from pulse oximetry in the operating room after the patients have rested for 5 min using a Masimo-finger pulse oximeter in the index finger. The preoperative PVI value taken at this point will be recorded as basal PVI. Spinal anaesthesia will be given with a 25G Quincke’s spinal needle in a sitting position with 15 mg of 0.5 per cent heavy bupivacaine. HR, SBP, MAP, SPO2, and PVI will be measured every minute for an initial 10 minutes and then every 5 minutes up to 30 minutes in a supine position. The sensory level will be checked using a spirit swab for a cold sensation. The assessment of motor blockade will be done using a modified Bromage scale. The surgery will commence once the T6 dermatomal level is achieved. Hypotension is defined as SBP less than 90 mmHg or a 20 per cent fall from baseline or MAP less than 65 mmHg. Hypotension will be treated with Inj. Ephedrin 6 mg bolus and Fluid bolus of RL at 10 to 15ml per kg. |