| CTRI Number |
CTRI/2026/01/100573 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective and Comparative Study |
| Study Design |
Other |
|
Public Title of Study
|
Does Diabetes Make It Harder for Doctors to Manage a Patient’s Airway During Surgery? |
|
Scientific Title of Study
|
Comparing difficult airway predictors for intubation
difficulty: Diabetic versus Non-Diabetic Patients |
| 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 Vadher raj bharatbhai |
| Designation |
Pg resident |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
Department of Anesthesia OT complex 2nd floor Mahatma Gandhi
hospital Sitapura Jaipur Rajasthan
India
Jaipur RAJASTHAN 302022 India |
| Phone |
8460502527 |
| Fax |
|
| Email |
dr.rajvadher@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr priyamvada gupta |
| Designation |
Professor,Anaesthesia |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
Department of Anesthesia OT complex 2nd floor Mahatma Gandhi
hospital Sitapura Jaipur Rajasthan
India
Jaipur RAJASTHAN 302022 India |
| Phone |
7976568252 |
| Fax |
|
| Email |
drpriyamvada@hotmail.co.uk |
|
Details of Contact Person Public Query
|
| Name |
Dr kalpana verma |
| Designation |
Professor, Anaesthesia |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
Department of Anesthesia OT complex 2nd floor Mahatma Gandhi
hospital Sitapura Jaipur Rajasthan
India
Jaipur RAJASTHAN 302022 India |
| Phone |
7727886029 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi hospital Sitapura, Jaipur, Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college and hospital |
| Address |
Department of anesthesia and critical care , Mahatma Gandhi
hospital, sitapura , jaipur, rajasthan, india 302022 |
| Type of Sponsor |
Private 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 Raj Bharatbhai Vadher |
Mahatma Gandhi medical college and hospital |
Department of anesthesia
Mahatma Gandhi
hospital Sitapura jaipur
rajasthan Jaipur RAJASTHAN |
8460502527
vadherraj11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATMA GANDHI UNIVERSITY OF MEDICAL SCIENCES & TECHNOLOGY, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-70 years
Patients of all genders
Patients posted for surgery under general anaesthesia
requiring endotracheal intubation.
ASA Grade 1/2/3 |
|
| ExclusionCriteria |
| Details |
Patients with the previous history of difficult intubation
Obvious anatomical deformity (congenital, traumatic,
post surgical origin) of face, neck, palate and hands.
Coexisting factors like rheumatoid arthritis, large thyroid,
airway trauma.
Emergency surgeries.
Pregnant & lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the single best clinical
parameter of airway assessment and its ability to predict
difficult intubation (measured by CL grading) in patients with
diabetes mellitus (DM). |
30 minutes after induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out if prolonged diabetes more than 10
years correlates with increased difficulty in intubation |
30 minutes after induction of general anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
30/01/2026 |
| 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="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective hospital based comparative study will be conducted in the Department of Anaesthesia Mahatma Gandhi Medical College and Hospital Jaipur after ethical committee approval Informed written consent will be obtained from all patients Patients will be allocated into two groups of one hundred each based on diabetic and non diabetic status Group D Diabetic patients n equals one hundred Group ND Non diabetic patients n equals one hundred On the day before surgery the patient will be examined in the sitting position and the following indices will be assessed Body mass index Inter incisor distance Neck extension Neck circumference Mallampati score Thyromental distance and sternomental distance upper lip bite test Prayer sign Palm print sign On the day of surgery doses of anti diabetic agents will be withheld Six hours of fasting will be ensured Morning fasting blood sugar will be measured and an intravenous line will be secured In the operation theater adequate intravenous access will be confirmed Standard monitoring will be attached Non invasive blood pressure pulse oximetry electrocardiogram and end tidal carbon dioxide will be monitored after intubation Before induction of anesthesia all patients will receive intravenous glycopyrrolate zero point two milligrams intravenous midazolam one milligram and intravenous fentanyl two micrograms per kilogram Anesthesia will be induced with intravenous propofol one point five to two milligrams per kilogram followed by intravenous atracurium zero point five milligrams per kilogram Laryngoscopy will be performed after three minutes with the patient head in morning air sniffing position using a standard appropriate sized Macintosh blade The laryngeal view will be graded according to the Cormack and Lehane classification The patient trachea will be intubated with an appropriate size endotracheal tube and correct placement of the tube will be confirmed by capnography and chest auscultation In case of difficulty maneuvers and adjuncts such as external laryngeal manipulation change in head position use of different size or type of laryngoscope blade and intubating bougie will be employed The outcome measure will be the Cormack and Lehane grading of laryngoscopy |