| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|