| CTRI Number |
CTRI/2023/11/060320 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, propofol and thiopentone on airway changes in patients during general anaesthesia |
|
Scientific Title of Study
|
Assessment and comparison of airway mechanics during bag mask ventilation using propofol and thiopentone as induction agents. |
| 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 Sanjay Johar |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416050652 |
| Fax |
|
| Email |
sanjays321@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Das |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7044071655 |
| Fax |
|
| Email |
anuragdas019@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Das |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7044071655 |
| Fax |
|
| Email |
anuragdas019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, PGIMS, Rohtak, Haryana, 124001, INDIA |
| 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 Anurag Das |
Pt BD Sharma PGIMS Rohtak |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA |
7044071655
anuragdas019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee Pt. B. D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol |
Intravenous Propofol (10 mg/ml) of dose titrated to achieve a BIS value of 40-50 will be given at the time of induction of Anesthesia. |
| Comparator Agent |
Thiopentone |
Intravenous Thiopentone (25 mg/ml) of dose titrated to achieve a BIS value of 40-50 will be given at the time of induction of Anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II.
Posted for elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Anticipated difficult bag mask ventilation (history of snoring, obesity, large tongue, tonsillar hypertrophy, edentulous and presence of beard etc) and difficult airway (mouth opening less than 3 cm, MPG grade 3 and 4, TMD less than 6.5 cm, restricted neck movements and inability to extend the lower incisor beyond upper incisor)
Pregnant patient
BMI more than 30 kg/m2
Respiratory disease, increased risk of aspiration
Requiring awake intubation
History of allergy to study drugs
Refusal to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of static and dynamic compliance during bag mask ventilation after induction with thiopentone and propofol. |
30 sec after achieving clinical end point of induction with thiopentone /
propofol and till 30 sec after that (TI, TI1, TI2, TI3, TI4, TI5, TI6 i.e. 30s, 35s, 40s, 45s, 50s, 55s & 60s after induction respectively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and assess
1. Peak inspiratory pressure (PIP) and plateau pressure (PP) at induction & after muscle
relaxant (MR)
2. Ratio of expiratory and inspiratory tidal volume (VTe / VTi) after induction & MR
3. Compliance during bag mask ventilation after MR
4. Ease of mask ventilation (Han’s grading scale)
5. Any other adverse effects (bronchospasm, increase airway pressure, hypertension,
hypotension, bradycardia, tachycardia, desaturation) |
150 sec after giving relaxant and till 30s after that (TM, TM1, TM2, TM3,
TM4, TM5, TM6 i.e. 150s, 155s, 160s, 165s, 170s, 175s, 180s after muscle relaxant respectively) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2023 |
| Date of Study Completion (India) |
27/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
The prospective study was conducted in the department of anaesthesia and critical care, PGIMS, Rohtak. Written informed consent were taken from patients included. Then assessment and comparison of airway mechanics was done during bag and mask ventilation using propofol and thiopentone as induction agents. Data were compiled and analysed with appropriate statistical test. |