CTRI

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CTRI Number

CTRI/2025/11/096924 [Registered on: 06/11/2025] Trial Registered Prospectively

Last Modified On:

04/11/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Biological
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study comparing stomach volume using ultrasonography in patients posted for surgery who have not eaten or drunk anything versus those who drank 200 ml of coconut water 2 hours before planned surgery.

Scientific Title of Study

Assessment of Gastric Residual Volume Using Ultrasonography in fasted patients versus patients receiving 200ml of Coconut Water 2 Hours before any elective surgery – A Randomized Controlled Trial

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 Karan Singh
Designation	Post Graduate Resident, Department of Anaesthesiology
Affiliation	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India Khordha ORISSA 751024 India
Phone	7739811175
Fax
Email	711karan.panesar@gmail.com

Details of Contact Person
Scientific Query

Name	Dr T Rajmohan Rao
Designation	Professor Department of Anaesthesiology
Affiliation	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India Khordha ORISSA 751024 India
Phone	9701185818
Fax
Email	trajmohan.rao@kims.ac.in

Details of Contact Person
Public Query

Name	Dr T Rajmohan Rao
Designation	Professor Department of Anaesthesiology
Affiliation	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India Kalinga Institute of Medical Sciences, Bhubaneswar Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa- 751024 Khordha ORISSA 751024 India Khordha ORISSA 751024 India
Phone	9701185818
Fax
Email	trajmohan.rao@kims.ac.in

Source of Monetary or Material Support

Kalinga Institute of Medical Sciences,Bhubaneswar,Orissa,District Khorda, PIN 751024

Primary Sponsor

Name	Kalinga Institute of Medical Sciences, Bhubaneswar
Address	Kushabhadra Campus5, KIIT Road, Bhubaneswar, Odisha-751024
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr karan	Kalinga Institute of Medical Sciences	Kalinga Institute of Medical Sciences, Kushabhadra Campus 5, KIIT Road, Bhubaneswar Khordha ORISSA Khordha ORISSA	7739811175 711karan.panesar@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Kalinga Institute of Medical Sciences ( KIMS), KIIT Deemed to be University, Bhubaneswar- 751024	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical, (2) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	group f fasting	Group F – Patients who do not receive any clear fluids 2 hours before the elective surgery.
Intervention	200 ml of pulp free coconut water	two before Surgery
Intervention	group c cocunut water	Group C – Patients who receive 200ml of pulp free clear Coconut water 2 hours before the elective surgery.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Age: 18 – 65 years 2.ASA physical status I and II 3.Elective Surgery

ExclusionCriteria

Details

•Patients refusal
•Patients HBA1c levels more than 7percent or fasting blood suger more than 150mg per dl (8 point 3 mmol per L) 2 hours before the Surgery
•Patient undergoing emergency surgeries
•Chronic kidney disease
•Patient potassium values more than 5 mmol per L
•Pregnant women
•Patients undergoing bowel surgeries
•Patients with large abdominal mass

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
All patients will demonstrate low gastric residual volume less than one and half ml per kg supporting safe gastric emptying of pulp free coconut water within two hours	two hours from ingestion

Secondary Outcome

Outcome	TimePoints
A potential reduction in the post operative nausea & vomiting owing to the hydration & electrolyte balancing properties of coconut water	Two hours post surgery

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)

15/11/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

15/11/2025

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)

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 randomized controlled trial aims to evaluate the safety and effect of coconut water intake 2 hours prior to elective surgery by assessing gastric residual volume (GRV) using ultrasonography and monitoring postoperative nausea and vomiting (PONV).

According to current guidelines from the American Society of Anesthesiologists (ASA), clear fluids are permitted up to 2 hours before surgery. Coconut water, being a natural, clear fluid rich in electrolytes, may serve as a suitable option. However, its gastric emptying profile is not well-established.

The study involves two groups of patients (aged 18–65, ASA I & II):

Group F: Fasted patients (no fluids 2 hours before surgery)
Group C: Patients receiving 200 ml of pulp-free coconut water 2 hours before surgery

Pre-induction gastric ultrasonography will be used to measure the antral cross-sectional area (CSA) and estimate GRV. A GRV of <1.5 ml/kg is considered safe. PONV will be assessed for 2 hours postoperatively using a standardized scoring system.

The study will enroll up to 100 patients (50 per group) over a maximum of 2 years at KIMS, Bhubaneswar.

Primary Objective

Compare GRV between fasted patients and those receiving coconut water.

Secondary Objective

Assess PONV scores in both groups.

Expected Outcomes

Coconut water will not increase GRV beyond safe limits.
It may reduce PONV due to better hydration and electrolyte balance.

The study addresses a research gap regarding the preoperative safety of coconut water, using non-invasive gastric ultrasonography as an objective tool. Results may support coconut water as a safe, effective clear fluid option before elective surgery.