| 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
|
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Shaheed Bhagat Singh Marg,
New Delhi |
| 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 |
| 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
|
|
|
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
|
|
|
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. |