Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia

Study Overview
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Brief Summary
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Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.

Detailed Description
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Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia. Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.

Official Title
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Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia

Conditions
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Pulmonary Aspiration of Gastric Contents

Intervention / Treatment
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* Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume
* Procedure: Nasogastric Aspiration for Measurement of Gastric pH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female patients Age between 1 to 12 years Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia Exclusion Criteria: 1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Total 120 patients will be randomly allocated into two groups using computerized generated numbers (60 in each group). Group A with 6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively. Group B with 6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long NPO group<br>6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively | Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume<br>* The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.<br>Procedure: Nasogastric Aspiration for Measurement of Gastric pH<br>* The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.<br>|
| Experimental: Short NPO group<br>6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively | Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume<br>* The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.<br>Procedure: Nasogastric Aspiration for Measurement of Gastric pH<br>* The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean residual gastric volume | Mean Residual Gastric Volume will be measured in mililiter | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric pH | Gastric pH will be measured by pH Litmus paper | 6 months |