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CTRI Number  CTRI/2014/11/005209 [Registered on: 19/11/2014] Trial Registered Prospectively
Last Modified On: 30/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Cost of general anaesthesia 
Scientific Title of Study   Cost identification analysis of general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LHMC/ECHR/2014/436  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Malhotra 
Designation  PG Student 
Affiliation  Lady Hardinge Medical college 
Address  Department of Anaesthesia, Lady Hardinge Medical college, Shaheed Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone  9911203165  
Fax    
Email  rohitmalhotra143@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aruna Jain 
Designation  Dir Prof and Head 
Affiliation  Lady Hardinge Medical college 
Address  Department of Anaesthesia, Lady Hardinge Medical college, Shaheed Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone  23408258  
Fax    
Email  ajayaruna112@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Rohit Malhotra 
Designation  PG Student 
Affiliation  Lady Hardinge Medical college 
Address  Department of Anaesthesia, Lady Hardinge Medical college, Shaheed Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone  9911203165  
Fax    
Email  rohitmalhotra143@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed Bhagat Singh Marg, New Delhi 
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 
Rohit Malhotra  Main OT, ground Floor, Department of Anaesthesiology  Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi
New Delhi
DELHI 
9911203165

rohitmalhotra143@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for human research, LHMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients for elective surgery 1-4 hours duration requiring general anaesthesia with endotracheal intubation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 yrs of either sex
ASA I and II
Planned for elective surgeries under general
anaesthesia with endotracheal intubation
Surgical duration 1-4 hours
 
 
ExclusionCriteria 
Details  Patient undergoing surgery under regional block
Regional block supplemented with general
anaesthesia
Surgeries with any adverse intraoperative event
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the variable cost associated with different modalities of general anaesthesia  To estimate the variable cost associated with different modalities of general anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify the variable cost per case of general anaesthesia.
2. To calculate the cost of general anaesthesia per hour and per patient per hour
3. To calculate the cost of drug wastage as percentage of total cost with different modalities of general anaesthesia. 
After completion of study 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "258"
Final Enrollment numbers achieved (India)="258" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/11/2014 
Date of Study Completion (India) 26/01/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Data will be published after completion of study in medical journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

With the introduction of new and advanced techniques, the healthcare costs have also increased progressively. Limited budget allocation for health in developing nations makes it difficult to embrace these advancements. One of the major expenditures in a hospital has been attributed to anaesthetic procedures. It thus becomes challenging for the anesthesiologist to use newer techniques that help maintain the standards of patient safety yet are cost effective in routine use.

The market for surgery and anaesthesia does not follow conventional supply/ demand and cost/quality equilibrium laws. This is known as market failure, a situation that calls for special strategies for controlling costs and assessing tradeoffs. This has led to work force modifications to determine if clinical practice is associated with best outcome result at a reasonable cost – a concept termed value based anaesthesia care.

In economic terms, it can be evaluated by cost identification (minimization) analysis which involves comparison of acquisition costs of various anaesthesia techniques (is least expensive) providing the desired outcome.

Another method of minimizing costs is to reduce wastage, that is, drug is loaded but not used for the patient and is discarded at the end of the procedure. Studies illustrate that using drugs judiciously will eventually reduce costs but fail to elucidate the techniques associated with less wastage.

Although studies have compared different anaesthetic techniques (eg spinal vs general anaesthesia) for a particular surgery with respect to their cost efficacy, patient safety and side effects, or two different general anaesthetic techniques (high flow and low flow inhalational anaesthesia with one agent or low flow anaesthesia with total intravenous anaesthesia), a comprehensive analysis of cost identification for general anaesthesia is lacking. 

 
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