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CTRI Number  CTRI/2023/10/058610 [Registered on: 13/10/2023] Trial Registered Prospectively
Last Modified On: 09/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study/ Surgical/Anaesthesia 
Study Design  Other 
Public Title of Study   Comparison of STOP-BANG and Berlin Questionnaire in the prediction of overweight and obese patients developing desaturation during general anaesthesia 
Scientific Title of Study   Comparison of STOP-BANG and BERLIN questionnaire in the prediction of overweight and obese patients developing desaturation during induction of general anaesthesia  
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshitha Jayakumar 
Designation  Junior Resident  
Affiliation  JSS Academy of Higher Education and Research 
Address  Department OF Anaesthesiology, JSS HospitalL, Mysuru, Karnataka - 570004

Mysore
KARNATAKA
570004
India 
Phone  9566066513  
Fax    
Email  DR.AKSHITHAJK@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  DR. Srinivas H T 
Designation  Associate Professor 
Affiliation  JSS Academy of Higher Education and Research 
Address  Department OF Anaesthesiology, JSS Hospital, Mysuru, Karnataka - 570004

Mysore
KARNATAKA
570004
India 
Phone  9986079823  
Fax    
Email  DRSRINIVASHTJSS@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  DR Srinivas H T 
Designation  Associate Professor 
Affiliation  JSS Academy of Higher Education and Research 
Address  Department of Anaesthesiology, JSS Hospital, Mysuru, Karnataka - 570004

Mysore
KARNATAKA
570004
India 
Phone  9986079823  
Fax    
Email  DRSRINIVASHTJSS@GMAIL.COM  
 
Source of Monetary or Material Support  
JSS Medical College and Hospital, MG Road, Agrahara, Mysuru - 570004 
 
Primary Sponsor  
Name  JSS Academy of Higher Education and Researcg 
Address  JSS Medical College and Hospital, MG Road, Near Agrahara Circle, Mysore, Karnataka - 570004 
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 Akshitha Jayakumar  JSS MEDICAL COLLEGE AND HOSPITAL  Patients of general surgery, surgical gastroenterology, ENT, Obstetrics and Gynaecology posted for elective surgeries under general endotracheal anaesthesia, 3rd floor and 2nd floor OT complex, MG Road, Agrahara, Mysore, Karnataka - 570004
Mysore
KARNATAKA 
9566066513

DR.AKSHITHAJK@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jss Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (5) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (6) ICD-10 Condition: G00-G99||Diseases of the nervous system, (7) ICD-10 Condition: O||Medical and Surgical, (8) ICD-10 Condition: O||Medical and Surgical, (9) ICD-10 Condition: E66||Overweight and obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients between the ages of 18 years and 60 years

2) ASA grade I-II of either gender

3) BMI greater than or equal to 25

4) Posted for elective surgery under general endotracheal anaesthesia

5) Informed consent given 
 
ExclusionCriteria 
Details  - Patients undergoing emergency surgeries
- Contraindications to any of the general anaesthetics or muscle relaxants (such as succinylcholine)
- Allergy to anaesthetics
- Already diagnosed cases of OSA who are on treatment (such as CPAP)
- Smokers
- Diagnosed cases of COPD
- Diagnosed cases of severe cardiac disease
- Patients with scoliosis
- Patients with restrictive lung disease
- Patient refusal for the procedure  
 
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 record the onset of desaturation & time taken to reach oxygen saturation of 93% on room air.  After induction (loss of eyelash reflex) as the time taken from the administration of succinylcholine till the first sign of fall in saturation upto 93% on room air within the first one minute. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess airway complications associated with overweight & obese patients undergoing general endotracheal anaesthesia   From the time of induction of general anaesthesia upto two hours in the post-operative period. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/10/2023 
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="6"
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  

Following approval from the Institutional Ethical Committee, informed consent will be taken from 100 patients satisfying the inclusion criteria will be allocated by Randomization using shuffled Sealed Envelope Technique. Patients will be allotted into 2 groups namely Group 1 (assessed by the Berlin Questionnaire) and Group 2 (assessed by the STOP-BANG Questionnaire). 

Total number of patients 100, with 50 patients in each group. 

1. Group 1 (n=50) : screened by the Berlin Questionnaire 

2. Group 2 (n=50) : screened by the STOP-BANG Questionnaire

All patients will be admitted before the surgery and pre anaesthetic evaluation will be done. Fasting of 6 hours for solids and 2 hours for clear liquids will be ensured. 


After obtaining written informed consent, patients between the ages of 18 years up to the age of 60 years belonging to ASA grade of I–II of either gender, with BMI greater than or equal to 25 posted for elective surgery under general endotracheal anaesthesia will be included in the study. Patients less than the age of 18 years or greater than 60 years, belonging to ASA grades III and above, having BMI less than 25, undergoing emergency surgeries, with contraindications to any of the general anaesthetics or muscle relaxants (such as succinylcholine), allergy to anaesthetics, already diagnosed cases of OSA who are on treatment (such as CPAP) will be excluded from the study.


On the day of surgery Intravenous (IV) access will be secured. In the operation theatre standard monitoring devices will be attached, including noninvasive arterial blood pressure, ECG and peripheral oxygen saturation probe using the GE Medical Systems Information Technologies, Inc. B125M Patient Monitor. Baseline readings will be recorded.

With the patient in supine position, patients will be appropriately premedicated with premedicants Inj. Ondansetron (4mg), Inj. Midazolam (1mg), Inj. Glycopyrrolate (0.2mg) and Inj. Fentanyl (1mcg/kg body wt). Patients from both the groups will be preoxygenated for three minutes with 100% oxygen, using closed circuit keeping total fresh gas flow at 10 litres. After this, patients will be administered 1.5mg/kg/body weight of IV lidocaine (preservative free), followed by induction with 1% Propofol 2 mg/kg, till there is loss of eye lash reflexes.


After trial ventilation and assessing for demonstrable bag and mask ventilation, depolarising muscle relaxant Inj. Succinylcholine 1.5 mg/Kg is administered for facilitating laryngoscopy & intubation. If bag and mask ventilation was difficult, patients were excluded from the study. Upon induction bag and mask ventilation is withdrawn briefly. Airway is maintained by triple manoeuvre (Head tilt, chin lift and jaw thrust).


Thereafter, the investigator will assess and record the time taken for the oxygen saturation to reach upto 93%. Intraoperative and postoperative desaturation events and other airway complications will also be observed and documented. (SpO2 cut-off: upto 93% in Room Air via peripheral oxygen saturation i.e., pulse oximetry).


The parameters assessed will be -


1. Desaturation onset time : Desaturation onset time will be considered after induction (loss of eyelash reflex) as the time taken from the administration of Succinylcholine till the first sign of fall in saturation from maximum saturation.


2. Period of desaturation : Period of desaturation will be considered after induction (loss of eyelash reflex) and administration of succinylcholine as the time taken for the saturation to drop to 93% on RA from the desaturation onset time.

3. Difficult Airway Events : Difficulty airway events including use of advanced airway, number of intubation attempts, need for reintubation after extubation and airway trauma.


Bag and mask ventilation will be resumed immediately followed by endotracheal intubation with mechanical ventilation. The peripheral oxygen saturation will be recorded heart rate and arterial pressure will be recorded at 0 and then at 3min intervals for the first 15 mins and then every 10 mins till end of surgery.

Hypotension (20% or more decrease in mean arterial blood pressure [MAP] from the baseline value) will be treated with boluses of IV Mephentermine (6 mg) and crystalloid infusion until the normotensive state is achieved. Bradycardia (20% or more decrease in heart rate [HR] from the baseline value) will be treated with 0.6 mg IV atropine. 

On extubation, patient will be observed for any desaturation (SpO2 less than 92% on Room Air). Patient will be observed for any desaturation and will be managed with O2 mask and or side effects such as nausea and vomiting in the post operative period.



 
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