| CTRI Number |
CTRI/2025/07/091810 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Ultrasonography to Compare Stomach Fullness Before Brain Surgery in Two Groups: One Following a Fast-Track Recovery Plan and One Following the Usual Plan |
|
Scientific Title of Study
|
Comparison of Preoperative Ultrasonographic Gastric Volume Assessment in Patients on ERAS protocol versus Conventional protocol undergoing Elective Intracranial Neurosurgery |
| 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 Ashish Patyal |
| Designation |
Associate Professor |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Department of Anaesthesia,
2nd Floor, Geetanjali Medical College and Hospital, Manwa Kheda, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9004600184 |
| Fax |
|
| Email |
aspatyal501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Patyal |
| Designation |
Associate Professor |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Department of Anaesthesia,
2nd Floor, Geetanjali Medical College and Hospital, Manwa Kheda, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9004600184 |
| Fax |
|
| Email |
aspatyal501@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Patyal |
| Designation |
Associate Professor |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Department of Anaesthesia,
2nd Floor, Geetanjali Medical College and Hospital, Manwa Kheda, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9004600184 |
| Fax |
|
| Email |
aspatyal501@gmail.com |
|
|
Source of Monetary or Material Support
|
| Geetanjali Medical College and Hospital, Geetanjali Medicity, Hiran Magri Extention, Eklingpura Chouraha, Manwa Kheda, Udaipur-313001, Rajasthan, India. |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Patyal |
| Address |
2nd Floor, Department of Anaesthesia, Geetanjali Medical College and Hospital, Geetanjali Medicity, Hiran Magri Extention, Eklingpura Chouraha, Manwa Kheda, Udaipur-313001, Rajasthan, India. |
| 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 Ashish Patyal |
Geetanjali Medical College and Hospital |
2nd floor, Department of Anaesthesia,
Udaipur
RAJASTHAN |
9004600184
aspatyal501@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee Geetanjali University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Body mass index BMI greater than 35 kg per metre squared
American Society of Anesthesiologists ASA classification 1 and 2
Patient with brain tumor with symptoms and signs of raised ICP
Patient with GCS greater than 13
Schedule for elective intracranial neurosurgery
|
|
| ExclusionCriteria |
| Details |
Any abnormal anatomy of the upper gastrointestinal system like previous esophagus or gastric surgery including hiatus hernia
Patient with active gastric or duodenal ulcer and upper gastrointestinal system bleeding
Patient with Vagal nerve denervation
Patient on opioids less than 8 hrs duration
Patient with infiltrative diseases such as scleroderma or amyloidosis
Pregnant patients
Patients with uncontrolled Diabetes Mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the correlation between duration of fasting and gastric volume in patients with brain tumors, on ERAS protocol versus Conventional protocol. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess & compare the effect on gastric emptying time on tumor location between the two groups. |
At baseline |
| To assess & compare the gastric emptying time in patients with comorbidities between the two groups ( DM , Hypertension etc). |
At baseline |
| To compare intra-operative blood glucose level between two groups . |
Intra-operatively at 1 hour from start of operation |
|
|
Target Sample Size
|
Total Sample Size="212"
Sample Size from India="212"
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)
|
01/09/2025 |
| 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="2"
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
|
This randomised controlled trial aims to evaluate and compare the preoperative gastric volume in patients undergoing elective intracranial neurosurgery under two different fasting protocols: the Enhanced Recovery After Surgery (ERAS) protocol and the traditional protocol. Gastric volume will be assessed using ultrasonography, and correlated with fasting duration, tumour location, co morbidities, and intra operative blood glucose levels. The study seeks to determine whether ERAS protocols, which include preoperative carbohydrate loading and shorter fasting durations, impact gastric emptying and aspiration risk in neurosurgical patients. This has the potential to improve peri operative safety and recovery by individualising preoperative fasting strategies. |