| CTRI Number |
CTRI/2026/02/103866 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of stomach emptying in patients with neck spine disorders using ultrasound |
|
Scientific Title of Study
|
Effect of different cervical spine pathologies on gastric emptying, using bed side ultrasound in adults patients- A prospective observational study. |
| 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 M NANDINI |
| Designation |
Junior resident |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room 10, Emergency block, 3rdfloor, department of anaesthesia,Nizams institute of medical sciences,Punjagutta, Hyderabad, Telangana.
Hyderabad
TELANGANA
500082
India |
| Phone |
7032472232 |
| Fax |
|
| Email |
mallelanandini9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Rao Kaluvala |
| Designation |
Additional professor |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room 2,old block,1st floor, department of anaesthesia, Nizams institute of medical sciences, punjagutta, Hyderabad, telangana.
Hyderabad
TELANGANA
500082
India |
| Phone |
9030460262 |
| Fax |
|
| Email |
drkprasadrao@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Nandini |
| Designation |
Junior resident |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room 10, emergency block, 3rd floor, department of anaesthesia, Nizams institute of medical sciences, punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
7032472232 |
| Fax |
|
| Email |
drkprasadrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams institute of medical sciences, punjagutta, Hyderabad 500082, India |
|
|
Primary Sponsor
|
| Name |
M Nandini |
| Address |
Room 10,3rd floor, emergency block, department of anaesthesia, Nizams institute of medical sciences, punjagutta, Hyderabad, 500082,India |
| Type of Sponsor |
Other [Self] |
|
|
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 MALLELA NANDINI |
Nizams institute of medical sciences ( NIMS), HYDERABAD |
Room 10, 4th floor, emergency block, department of neurosurgery, Nizams institute of medical sciences, punjagutta, Hyderabad, telangana, 500082
Hyderabad
TELANGANA |
7032472232
mallelanandini9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with cervical spine pathology either acute or chronic and traumatic or non traumatic etiology scheduled for elective cervical spine surgery belonging to ASA class 1 and 2 |
|
| ExclusionCriteria |
| Details |
High risk patients
Emergency surgery
Multiple comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess effect of cervical spine pathologies( acute vs chronic , traumatic vs non traumatic) on gastric emptying |
To assess effect of cervical spine pathologies( acute vs chronic , traumatic vs non traumatic) on gastric emptying |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To corelate demographic factors, effect of duration of disease, levels of spine involved on gastric emptying |
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/03/2026 |
| 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
|
Cervical spine pathologies, both traumatic and non-traumatic, are associated not only with motor and sensory deficits but also with significant autonomic dysfunction, including gastrointestinal (GI) motility disturbances. Disruption of sympathetic outflow with preserved vagal tone may lead to delayed gastric emptying (DGE), increasing the risk of aspiration during anesthesia, particularly in patients with anticipated difficult airways. Despite the clinical relevance, there is limited literature comparing gastric emptying patterns across different cervical spine pathologies. This prospective observational study aims to assess the effect of cervical spine diseases—classified as acute or chronic, traumatic or non-traumatic—on gastric emptying using bedside ultrasound. The study will recruit adult patients (aged 18–60 years) scheduled for elective cervical spine surgery, ASA I–II, over a period of one year at Nizam’s Institute of Medical Sciences. Exclusion criteria include emergency surgeries, ASA III–IV status, long-standing diabetes, chronic renal failure, GERD, BMI >40, polytrauma, and autonomic neuropathy. Gastric volume will be assessed using a curvilinear probe (2–5 MHz) in the right lateral position. The antral cross-sectional area (ACSA) will be measured using anteroposterior and craniocaudal diameters, and gastric volume will be calculated using the Perlas formula: Volume (mL) = 27 + 14.6 × ACSA (cm²) – 1.28 × age Baseline gastric volume (after 8 hours fasting) and postprandial volume (4 hours after a standard breakfast) will be recorded. Each time, three ultrasound readings will be averaged. Additional variables including type and duration of cervical pathology, use of cervical collar, neurological deficits, and comorbidities will also be documented. The study aims to identify high-risk subgroups requiring tailored fasting guidelines to optimize perioperative safety and minimize aspiration risk. |