| CTRI Number |
CTRI/2025/09/093990 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlating fasting duration before Operation with Ultrasound findings of stomach in non-emergency Cesarean deliveries |
|
Scientific Title of Study
|
Correlation of preoperative fasting duration with Gastric Ultrasound findings in elective Cesarean deliveries |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Oela Roy |
| Designation |
Post Graduate Trainee |
| Affiliation |
ESI PGIMSR and Hospital Manicktala |
| Address |
Department of Anaesthesiology
OT complex Third floor
ESI PGIMSR and Hospital
Manicktala
Kolkata
WEST BENGAL
700054
India |
| Phone |
9051525350 |
| Fax |
|
| Email |
oela.roy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Wasim Raja |
| Designation |
Senior Consultant and PG Thesis Guide |
| Affiliation |
ESI PGIMSR and Hospital Manicktala |
| Address |
Department of Anaesthesiology
OT complex Third floor
ESI PGIMSR and Hospital
Manicktala
Kolkata
WEST BENGAL
700054
India |
| Phone |
9831812151 |
| Fax |
|
| Email |
academics.esi@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Oela Roy |
| Designation |
Post Graduate Trainee |
| Affiliation |
ESI PGIMSR and Hospital Manicktala |
| Address |
Department of Anaesthesiology
OT Complex Third floor
ESI PGIMSR and Hospital
Manicktala
Kolkata
WEST BENGAL
700054
India |
| Phone |
9051525350 |
| Fax |
|
| Email |
oela.roy@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI PGIMSR and Hospital
Manicktala
54 Bagmari road
Manicktala
Kolkata - 700054
West Bengal
India |
|
|
Primary Sponsor
|
| Name |
ESI PGIMSR and Hospital Manicktala |
| Address |
54 Bagmari road
Kolkata 700054
West Bengal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Oela Roy |
ESI PGIMSR and Hospital Manicktala |
Department of Anaesthesiology
OT complex Third floor
ESI PGIMSR and Hospital
Manicktala
54, Bagmari road
Kolkata - 700054
West Bengal
India
Kolkata
WEST BENGAL |
9051525350
oela.roy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESI PGIMSR and Hospital Manicktala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O740||Aspiration pneumonitis due to anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Gestational Age: Non-labouring, term pregnant women (greater than and equal to 37 weeks gestation).
Procedure: Scheduled for elective cesarean section under spinal anesthesia.
Physical Status: American Society of Anesthesiologists (ASA) physical status II.
Body Mass Index (BMI): 18.5–40 kg per m² (ASA II)
Fasting Status: Patients who have followed preoperative fasting as per institutional practices. |
|
| ExclusionCriteria |
| Details |
Patients in labour.
Patients with exaggerated Aortocaval syndrome.
Multiple Gestation: Women with multiple pregnancies.
Emergency Procedures: Patients requiring emergency cesarean section.
Obstetric Complications graded III or beyond: Preeclampsia with severe features, gestational DM with complications or high insulin requirements, a thrombophilic disease requiring anticoagulation, etc.
Cases converted to general anaesthesia post spinal anaesthesia failure.
Refusal to Participate: Declined or withdrew consent at any stage.
Mentally incompetent: unable to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Qualitative: Perlas grading
Quantitative: Gastric volume by measuring antral Cross-sectional area.
|
Ultrasound scans and its real time assessment will be done 10 minutes before giving spinal anaesthesia in cesarean delivery surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative Nausea & vomiting |
Intraoperative symptoms like nausea & vomiting will be assessed every 10 minutes during the surgery. |
| Intraoperative Capillary blood glucose |
Capillary Blood Glucose will be assessed once during the surgery at any given point. |
| Intraoperative discomfort & anxiety |
Intraoperative symptoms like patient discomfort will be assessed every 10 minutes during the surgery.
|
|
|
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)
|
15/09/2025 |
| 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="0"
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
|
Perioperative aspiration is a major cause of mortality especially among pregnant patients due to their physiological changes. In our country, noncompliance to recommended fasting guidelines is frequently observed and perioperative safety in obstetric cases is compromised by both short and prolonged fasting durations.
The Aim of this study is to find correlation between preoperative fasting durations with gastric ultrasound findings and intraoperative clinical features like intraoperative nausea and vomiting, capillary blood glucose and overall patient discomfort and anxiety.
The objectives are Evaluation of real world fasting practices among parturient scheduled for elective cesarean delivery under spinal anaesthesia. Ensure perioperative obstetric safety and reduce the aspiration risk. To find scopes for refine, revalidate and individualise the current fasting guidelines. |