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CTRI Number  CTRI/2024/05/066637 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   The usefulness of plethysmography in predicting spinal anaesthesia-induced hypotension in elderly patients 
Scientific Title of Study   Utility of Pleth Variability Index (PVI) in Predicting Spinal anaesthesia-induced hypotension in elderly patients: A prospective diagnostic test 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  Sujeet Sagar 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of anaesthesia and intensive care, Nehru hospital 4th floor, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  sujeetorlenin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajay Singh 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of anaesthesia and intensive care, Nehru hospital 4th floor, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008084  
Fax    
Email  ajay.ydv2509@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajay Singh 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of anaesthesia and intensive care, Nehru hospital 4th floor, Post Graduate Institute of Medical Education and Research, Chandigarh


CHANDIGARH
160012
India 
Phone  7087008084  
Fax    
Email  ajay.ydv2509@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh-160012, India 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education ResearchChandigarh 
Address  Sector-12. Chandigarh. 160012 
Type of Sponsor  Research institution and hospital 
 
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 Sujeet Sagar  Post Graduate Institute of Medical Education and Research, Chandigarh  Nehru hospital 4th floor, Post Graduate Institute of Medical Education and Research,Chandigarh 160012
Chandigarh
CHANDIGARH 
7023756206

sujeetorlenin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Post Graduate Institute of Medical Education & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  not applicable 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patient undergoing spinal or spinal-epidural anaesthesia
2.ASA-PS I/II
3.Patients undergoing elective surgery
 
 
ExclusionCriteria 
Details  1.BMI more than 35 kg/m2
2.Pre-existing hypotension or shock
3.Any contraindication to spinal anaesthesia
4.Cardiac dysfunction (EFless than 40%, arrhythmias)
5.Known peripheral vascular disease/vasculitis
6.Patients with less than 15-sec breath holding time
• Failed spinal anaesthesia

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To determine the predictive value of Pleth variability index (PVI) at the end of a 15-sec maximal inspiratory breath hold in the sitting position before spinal anaesthesia in predicting the occurrence of hypotension, defined as a fall in MAP by 20% from baseline or SBP less than 80 mm of Hg in elderly patients.  Baseline and every 2 minutes for 10 minutes, followed by every 5 minutes till 30 minutes from spinal drug injection. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the predictive value of change in PVI (baseline & after 15 sec breath hold) & occurrence of post-spinal hypotension in elderly patients.
2. To determine the predictive value of baseline PI in the development of hypotensive response to spinal anaesthesia.
3. To find the incidence of hypotension in the elderly population following spinal anaesthesia.
4. Incidence of baseline hypothermia
 
From induction of spinal anaesthesia to 24 hours after surgery 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/05/2024 
Date of Study Completion (India) 01/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/05/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

 After approval from the Institutional Ethics Committee, PGIMER, Chandigarh, written informed consent will be obtained from all the patients before enrollment in this prospective diagnostic study.

 

Pre anaesthesia evaluation

 

· All the patients will undergo standard pre-anaesthesia checkups along with breath-holding time. Those patients who meet the inclusion and exclusion criteria will be included in the study.

 

Before spinal anaesthesia

 

·      Once the participant enters the operating theatre, he/she will be asked to lie supine on the table. Concurrently, the ASA (American Society of Anaesthesiologists) standard monitors and the Masimo Radical 7® (Masimo Corp., Irvine, CA, USA) devices will be attached to the patient within the operating room premises. A warming device will also be applied to the patient, and the preoperative fasting period will be recorded.

 

·      Baseline parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), temperature, as well as baseline perfusion index (PI), and pleth variability index (PVI), will be recorded following a five-minute resting period.

 

·      Subsequently, the individual will be instructed to perform a breathing manoeuvre by taking a deep exhalation followed by a peak inhalation and a 15-second breath hold immediately before administering spinal anaesthesia. We will record the second Pleth Variability Index (PVI) at this juncture.

 

·      After recording 2nd PI and PVI values, intravenous crystalloid infusion will be started at the rate of 2 millilitres per kilogram per hour, will be initiated.

 

Administration of spinal anaesthesia

 

·      Under appropriate aseptic precautions, in the sitting position, the patient’s back will be painted with an antiseptic solution and draped. The antiseptic solution will be left to dry for a few minutes.

 

·      Meanwhile, the drug (Heavy Bupivacaine 10mg + Fentanyl 25 mcg) will be loaded in a syringe for intrathecal injection, maintaining sterile conditions. L4-L5 intervertebral space will be identified using Tuffier’s line as a landmark that passes from the highest point on the iliac crests.

 

·      Using 25G/26G Quincke’s spinal needle, a needle will be inserted in L3-L4 or L4-L5 intervertebral space through a midline or paramedian approach.

 

·      After the free flow of CSF is seen, the syringe will be locked tightly to the spinal needle, and the drug will be administered intrathecally to the patient in the L3-L4  or L4-L5 intervertebral space.

 

After spinal anaesthesia


·      After administration of sub-arachnoid block, NIBP(Non-invasive blood pressure) measurements will be cycled every 2 minutes for 10 minutes, followed by every 5 minutes till 30 minutes from spinal drug injection. The highest level of sensory and motor block will also be recorded.

·      A fall in MAP by 20% from baseline or SBP less than 80 mm of Hg at any of these time points will be considered anaesthesia-induced hypotension.

·      The hypotensive episode will be treated with an intravenous fluid bolus of 250 ml followed by phenylephrine 0.1 mics per Kg or Mephenteramine 3 to 6 mg boluses based on the heart rate and ongoing intravenous fluids if the hypotensive episode continues.

·      Duration of surgery and total intravenous fluid will also be documented.

 
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