| CTRI Number |
CTRI/2023/12/060851 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Purpose of this study is to compare the effect of two different anesthetic regimen
(Etomidate alone or Etomidate with Ketamine) that will be used to induce loss of
consciousness in patients (in order to alleviate the pain and agony during surgery) on
alteration of Serum Cortisol levels |
|
Scientific Title of Study
|
Effect of adding ketamine to etomidate infusion on serum cortisol levels for anesthetic induction compared to etomidate infusion alone in elective surgical patients: a randomized controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jency |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaestesiology and Critical care
Old hospital building
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry-605006
Department of Anaestesiology and Critical care
Old hospital building
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8807086186 |
| Fax |
|
| Email |
jencyedvin25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyaprakash MVS |
| Designation |
Professor in the department of Anaesthesiology and Critical Care |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaestesiology and Critical care
Old hospital building
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786184626 |
| Fax |
|
| Email |
munaganuri1975@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jency |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaestesiology and Critical care
Old hospital building
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry-605006
Department of Anaestesiology and Critical care
Old hospital building
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8807086186 |
| Fax |
|
| Email |
jencyedvin25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri nagar
Puducherry-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri nagar
Puducherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jency L |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Anaesthesiology department
2nd floor, Old hospital building
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri nagar
puducherry
Pondicherry
PONDICHERRY |
8807086186
jencyedvin25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K31||Other diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate and Ketamine combined infusion |
Ketamine solution will be prepared by mixing 2mL of ketamine (50mg/mL) with 8mL normal saline. The infusion will be prepared in a 20mL syringe by taking 10mL of Etomidate (2mg/mL) mixed with 10mL of diluted ketamine (10mg/mL) with a final concentration of etomidate - 1mg/mL and ketamine 5mg/mL. The infusion will be started at the rate of 50mcg/kg/min |
| Comparator Agent |
Etomidate infusion |
Etomidate infusion will be prepared in a 20ml syringe by taking 10mL of the drug Etomidate (with a concentration of 2mg/mL) and 10 mL of normal saline, with a final etomidate-1mg/mL concentration. The infusion will be started at the rate of 50mcg/kg/min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18-60 years posted for elective surgeries undergoing general anaesthesia
2)ASA class 1 & 2
|
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women
2)Patients belonging to NYHA class 3&4
3)Known case of adrenal insufficiency
4)Known case of seizure disorder
5)Patients on steroid therapy
6)Patients who may require intraoperative or postoperative steroids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in the serum cortisol levels after giving the allotted drugs (Etomidate or Etomidate and Ketamine) |
To compare the changes in the serum cortisol levels at baseline and after giving the allotted drugs (Etomidate or Etomidate and Ketamine) at 4hrs, 12hrs, and 24hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction in the etomidate dose requirement during induction of anesthesia between the two groups (Etomidate or Etomidate & Ketamine) |
To compare the reduction in the etomidate dose requirement during induction of anesthesia between the two groups (Etomidate or Etomidate & Ketamine) which is measured at the time of induction |
| The time required for serum cortisol level to return to pre-induction range |
The time required for serum cortisol level to return to pre-induction range by comparing the serum cortisol level measured at baseline,4hrs, 12hrs & 24hrs post induction |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The purpose of this study is to compare the effect of two
different anaesthetic regimen (Etomidate alone or Etomidate with Ketamine) that
will be used to induce loss of consciousness in patients (in order to alleviate
the pain and agony during surgery) on the alteration of Serum Cortisol levels.
2. Procedure/methods of the study. Cortisol is an hormone which is an essential
regulator of carbohydrate, protein and lipid metabolism, which is essential for
normal functioning of humans. In this study the patients will be alloted into
either of the two groups (Group E and Group KE) with equal possibilities of
getting into either of the group and both of these regimen can result in the
desired effect of loss of consciousness in patients while you undergo the
surgery. On reaching the operation theatre patients will be secured intravenous
cannula which is the routine practice to administer drugs and fluids while you
undergo surgery and two ml of blood will be taken for calculating baseline
cortisol values. Vitals such as heart rate and blood pressure will be measured
every 2 minutes . After this, patient will be administered with either
Etomidate only or Ketamine and Etomidate depending upon the random group in
which the patient is allotted (Group K or KE). Patient breathing will be
assisted by an anaesthesiologist after they attain loss of consciousness. Once the
patient is completely anesthetized by the allocated anesthetic drug endotracheal
tube will be inserted to maintain respiration during surgery. Patients blood
pressure and heart rate will be monitored at 1st ,3rd ,5th and 10th minute from
the time of loss of consciousness. .Once this is done, the pateint will be
managed as per the attending Anaesthesiologist and he/she will be instructed
not to administer steroids during or upto 24 hours. Similar to before the surgery,
3 more blood samples at 4, 12 and 24 hours after loss of consciousness will be
taken to estimate the change in serum cortisol levels after administration of
the allocated anesthetized drug. The suppression in serum cortisol level between
the intervention and the control arm will be compared by the samples taken
before induction and at 4 hours,12 hours and 24 hours. |