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CTRI Number  CTRI/2025/10/095616 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 04/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Utility of SPI to predict pain and agitation in patients undergoing ENT surgeries 
Scientific Title of Study   Utility of Surgical Plethysmographic Index (SPI) as a predictor of post operative pain and Emergence agitation in patients undergoing elective Otolaryngological surgeries: A prospective cohort 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  Joel Dias  
Designation  Post graduate 
Affiliation  St johns medical college 
Address  Room no 7 OT Complex, 2nd floor, St John’s Medical College and Hospital,John Nagar,Bangalore 560034
Room no 7 OT Complex, 2nd floor, St John’s Medical College and Hospital,John Nagar,Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  9686056710  
Fax    
Email  drjoeldias@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Moses Charles Dsouza 
Designation  Professor 
Affiliation  St johns medical college 
Address  Department of Anaesthesiology St John’s Medical College and Hospital Sarjapur road, koramangala, Bangalore 560034
Department of Anaesthesiology St John’s Medical College and Hospital Sarjapur road, koramangala, Bangalore 560034
Bangalore
KARNATAKA
560034
India 
Phone  7829000524  
Fax    
Email  mdsouzamedia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Joel Dias  
Designation  Post graduate 
Affiliation  St johns medical college 
Address  Room no 7 OT Complex, 2nd floor, St John’s Medical College and Hospital,John Nagar,Bangalore
Room no 7 OT Complex, 2nd floor, St John’s Medical College and Hospital,John Nagar,Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  9686056710  
Fax    
Email  drjoeldias@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care, St johns medical college bangalore  
 
Primary Sponsor  
Name  St johns medical college and hospital  
Address  Room no 7 ot complex 2nd floor, St John’s Medical College and Hospital, koramangala ,Bangalore 560034 
Type of Sponsor  Private 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 
Dr Joel Dias  St johns medical college   Room no 7, ot complex 2nd floor, St johns medical college hospital, koramangala, Bangalore 560034
Bangalore
KARNATAKA 
9686056710

drjoeldias@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commite st johns medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and female patients aged 18 to 65 years belonging to American Society of Anaesthesiologists(ASA)grade 1 and 2, scheduled for elective ENT surgeries 
 
ExclusionCriteria 
Details  1. Patient refusal/incapacity to consent
2. Cognitive impairement
3. Preoperative Chronic pain on medication
4. Peripheral neuropathy
5. Peripheral vascular disease
6. Uncontrolled hypertension.
7. Patients on Beta blockers
8. Patients with cardiac arrhythmias or greater than 1st degree heart block
9. Patients with greater than 5 years of diabetes
10. Starting of vasoactive drugs 30 mins prior to end of the surgery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Utility of spi to predict post operative pain.

 
Pre induction and post induction. Post surgical stimulus at end of surgery till just prior to extubation. Post extubation and every 3 minutes for 15 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Utility of spi as predictor of of Emergence agitation  Pre induction and post induction. Post surgical stimulus at end of surgery till just prior to extubation. Post extubation and every 10 minutes till discharge from pacu 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   15/10/2025 
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="6"
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   Introduction
The Surgical Plethysmographic Index (SPI) is a proprietary technology of the GE Healthcare ventilators, which is used intra operatively as a measure of adequacy of analgesia. Pain from surgical stimulus causes tachycardia and vasoconstriction due to sympathetic activation.
SPI is calculated using the formula: 100 - ( 0.33* HBI + 0.67* PPGA) where HBI is the Heart Beat Interval and PPGA is the Photoplethysmographic waveform Amplitude. Tachycardia leads to decrease in HBI and vasoconstriction leads to decrease in PPGA which would thereby give an increased SPI value.SPI ranges from 1 to 100 and an ideal range should be kept between 20 to 50 for adequate analgesia.
Emergence agitation is a post anaesthetic phenomenon in which emergence from general anaesthesia is accompanied by psychomotor features such as agitation, confusion, disorientation and violent behavior.
Intra operative inadequacy of analgesia is one of the primary causes for post operative pain and emergence agitation

Need for the study
The incidence of post operative pain in patients undergoing general anesthesia can range from 20% up to 80% . Post operative pain often leads to prolonged hospital stay and delayed recovery.
The incidence of Emergence agitation in patients undergoing general anaesthesia is around 21.3%  but in ENT surgeries it can go up to 55.4% . This can lead to serious complications such as self extubation, removal of arterial/ IV lines, injury to medical staff and damage to hospital property.
 There is a dearth of literature which studies the utility of SPI in predicting postoperative pain and Emergence agitation.
The conventional method of measuring intra operative adequacy of analgesia by using hemodynamics alone (NIBP and Heart Rate) is not always accurate and leads to either inadequate or excess of analgesic administration.
SPI is a simple, non invasive, real time monitoring of adequacy of intra operative analgesia and its utility will be tested through this study, to check if incidence of post operative pain and emergence agitation can be better predicted

Methodology

All relevant patient demographic details: Age, gender, surgery name, ASA grade, medication history and pre op ECG will be noted
Intraoperative
• Pre induction values of SPI, Heart Rate, Mean Arterial Pressure will be noted.
• Premedication with 0.03 mg/kg of injection midazolam, 10 mcg/kg of injection glycopyrrolate and induction will be with 2 mcg/kg of injection fentanyl intravenously and injection propofol at 2 mg/kg, along with muscle relaxation using injection Atracurium 0.5 mg/kg given intravenously.
• Post induction (prior to surgical stimulus) values of SPI, HR and MAP will be noted.
• Anaesthesia will be maintained with air, oxygen, IPPV, inhalational agent targeting a MAC 1-1.2 and top-up doses of injection Atracurium (0.1 mg/kg
• At the end of the surgery, once there is no surgical stimuli - SPI, HR and MAP values will be noted every 1 minute for 5 minutes until reversal. The residual neuromuscular blockade will be reversed at the end of surgery by using an injection of neostigmine 0.05–0.07 mg/kg and an injection of glycopyrrolate 10 mcg/kg. All values observed will be on the continuous scale.

• Post tracheal extubation, Emergence Agitation will be assesed using the modified Riker Sedation Agitation Scale every 10 minutes until discharge from the PACU.
• Total intra operative opiod usage will be noted at the end of every surgery

Postoperative:
• After extubation, patient will be admitted in the post operative room. Once able to communicate, Post operative pain will be assessed using Numeric Rating Scale(0-10) every 3 minutes for 15 minutes
• Emergence agitation will be assessed using the Modified Riker Sedation Agitation Scale (RSAS) post extubation and every 10 mins till discharge from PACU
 
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