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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
 
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
 
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