| CTRI Number |
CTRI/2023/10/058265 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence and Correlation of Difficult Neuraxial Block in Patients with Airway Difficulty |
|
Scientific Title of Study
|
Difficult Neuraxial Anaesthesia in Obese Patients and its Correlation with Airway Difficulty in a Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARSHIYA AGGARWAL |
| Designation |
PG JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR 32 CHANDIGARH |
| Address |
Anaesthesia department
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR 32 CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7986358276 |
| Fax |
|
| Email |
arshiya.aggarwal097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
PROFESSOR |
| Affiliation |
GMCH SECTOR 32 CHANDIGARH |
| Address |
ANAESTHESIA DEPARTMENT
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR 32 CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARSHIYA AGGARWAL |
| Designation |
PG JUNIOR RESIDENT |
| Affiliation |
GMCH SECTOR 32 CHANDIGARH |
| Address |
Anaesthesia Department
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR 32 CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7986358276 |
| Fax |
|
| Email |
arshiya.aggarwal097@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARSHIYA AGGARWAL |
| Address |
Anaesthesia Department
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR 32 CHANDIGARH |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR MANPREET SINGH |
Professor,Department of Anaesthesia,Government Medical College Sector 32 ,Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arshiya Aggarwal |
Government Medical College |
Anaesthesia Department
Government Medical College
Sector 32 Chandigarh
Chandigarh
CHANDIGARH |
7986358276
arshiya.aggarwal097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GMCH CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI ≥ 25 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Patients’ refusal
2. Neurological disease.
3. Coagulation defects.
4. Patients medicated with anticoagulation.
5. Local infection on site for performing block.
6. Patients with spinal deformities and positioning difficulties /compliance.
7. Patients with previous spine surgery or trauma to spine.
8. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To Determine The Incidence of Difficult Neuraxial Anaesthesia and Incidence of Difficulty in Airway in Obese Patients
2. To Observe the Correlation of Difficult Regional Anaesthesia and Difficult Airway in Obese Patients |
At Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
10/10/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The proposed study will be a prospective, observational study, which will be done in the Department of Anaesthesiology and Intensive Care, at Government Medical College and Hospital, Sector 32, Chandigarh. Patients with obesity (BMI ≥ 25 kg/m2) posted for elective orthopaedic, urological, gynaecological or general surgeries requiring central neuraxial blockade (spinal &/or epidural anaesthesia), will be studied. A relevant history will be elicited and general physical and systemic examination and routine investigations will be done. Preoperative airway assessment with Benumof’s 11 point airway assessment will be applied. Patient will be asked to sit on the operating table with back facing the anaesthesiologist and legs straight on the operating theatre table. Patient will be asked to flex his/her back so that intervertebral spaces can be identified. Then as per surgical requirement spinal anaesthesia ,epidural anaesthesia or combined spinal epidural anaesthesia will be provided by the anaesthesiologist. The difficulties encountered in SAB/ epidural block will be observed and noted, and the patient will be continuously monitored during surgery. The study will be terminated as soon as central neuraxial anaesthesia is administered. The difficulties observed in patients during administration of central neuraxial block will be noted as per gradings. This will provide the incidence of difficult central neuraxial block. The incidence of difficult airways in obese patients of northern India will be calculated as per observations of Benumof’s difficult airway assessment tool in preoperative assessment. It will be then observed and assessed that how many patients with difficult central neuraxial blockade have difficult airway features / predictors also. Then the correlation will be calculated. |