| CTRI Number |
CTRI/2024/06/068537 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Measuring the effect of two techniques of anaesthesia- total intravenous anaesthesia and inhalational anaesthesia on stress response to surgery |
|
Scientific Title of Study
|
Comparison of the stress response between total intravenous anaesthesia (TIVA) and inhalational anaesthetic technique in diabetic patients undergoing abdominal surgery using cortisol/ dehydroepiandrosterone sulphate (DHEAS) ratio |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivika Malik |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Dept. of Anaesthesiology
Maulana Azad Medical College
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9815706823 |
| Fax |
|
| Email |
98shivika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept. of Anaesthesiology
Maulana Azad Medical College
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
01123238058 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivika Malik |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept. of Anaesthesiology
Maulana Azad Medical College
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9815706823 |
| Fax |
|
| Email |
98shivika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak hospital, JLN Marg, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, JLN Marg, New Delhi, 110002 |
| 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 |
| Dr Shivika Malik |
Lok Nayak Hospital |
Department of Anaesthesiology
Maulana Azad Medical College
JLN Marg
New Delhi
New Delhi
DELHI |
9815706823
98shivika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inhalational anaesthesia |
The patient will be shifted to the operation theatre and standard ASA monitors will be attached, along with BIS.
Patients will be pre-medicated for general anaesthesia using Inj. Midazolam 0.02 mg/kg and Inj. Fentanyl 2 mcg/kg. Induction will be done using Marsh model of target control infusion (TCI) pump with Inj. Propofol Cet 3-6 mcg/ml. Inj. Vecuronium 0.1mg/kg will be given for muscle relaxation. Airway will be secured using endotracheal tube. All patients will be ventilated with pressure control ventilation mode to deliver tidal volume of 6 ml/kg IBW (FiO2: 50%).
Anaesthesia will be maintained with: Sevoflurane (1.0 to 1.5 MAC) with FiO2- 50% and Inj. Fentanyl 0.5 -1 mcg/ kg. |
| Intervention |
Total Intravenous Anaesthesia |
The patient will be shifted to the operation theatre and standard ASA monitors will be attached, along with BIS. Patients will be pre-medicated for general anaesthesia using Inj. Midazolam 0.02 mg/kg and Inj. Fentanyl 2 mcg/kg. Induction will be done using Marsh model of target control infusion (TCI) pump with Inj. Propofol Cet 3-6 mcg/ml. Inj. Vecuronium 0.1mg/kg will be given for muscle relaxation. Airway will be secured using endotracheal tube. All patients will be ventilated with pressure control ventilation mode to deliver tidal volume of 6 ml/kg IBW (FiO2: 50%).
General anaesthesia will be maintained with: Inj. Propofol infusion titrated according to BIS of 40-60 and Inj. Fentanyl 0.5- 1 mcg/kg. Anaesthetic depth during surgery will be kept in the range of 40-60 according to the bispectral index. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA II or III
2. Well controlled type 2 diabetic patients using oral hypoglycaemic agents or insulin.
3. Elective open abdominal surgery.
4. Duration of surgery 2 to 6 hours. |
|
| ExclusionCriteria |
| Details |
1. Diabetic ketoacidosis or diabetic neuropathy.
2. Hepatic and/or renal dysfunction.
3. Pancreatic cancer or islet cell tumours.
4. Patients receiving drugs with known effects on sympathetic response or hormonal secretion such as beta blockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum cortisol to DHEAS ratio before and after the surgery and comparing the values between the total intravenous anaesthesia and inhalational anaesthesia groups in T2DM patients. |
30 minutes before surgery
24 hours after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum glucose, insulin and C-peptide in diabetic patients receiving intravenous or inhalational anaesthesia at different points of time. |
30 minutes before surgery
24 hours after completion of surgery |
| Percentage of post operative complications and outcomes in TIVA and inhalational anaesthetic techniques in diabetic patients undergoing abdominal surgery using EPCO definitions at 24 hours after surgery. |
24 hours after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
20/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this study, we plan to measure the surgical stress response in diabetic patients undergoing elective abdominal surgeries in Lok Nayak Hospital, Delhi, using serum cortisol to dehydroepiandrosterone (DHEAS) ratio, serum insulin, serum C-peptide and glucose levels. The comparison will be done between two anaesthetic techniques- total intravenous anaesthesia (TIVA) and inhalational anaesthesia. A total of 76 patients will be enrolled in the study, with 38 patients in each group. The blood samples will be collected 30 minutes prior to the surgery and 24 hours after the completion of surgery. In addition to the surgical stress response, patient outcomes and post-operative complications will also be recorded. |