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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2021-12-03

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.

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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.

Conditions

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Pulmonary Aspiration of Gastric Contents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Long NPO group

6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively

Group Type ACTIVE_COMPARATOR

Nasogastric aspiration for measurement of Residual Gastric Volume

Intervention Type PROCEDURE

The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.

Nasogastric Aspiration for Measurement of Gastric pH

Intervention Type PROCEDURE

The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.

Short NPO group

6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively

Group Type EXPERIMENTAL

Nasogastric aspiration for measurement of Residual Gastric Volume

Intervention Type PROCEDURE

The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.

Nasogastric Aspiration for Measurement of Gastric pH

Intervention Type PROCEDURE

The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.

Interventions

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Nasogastric aspiration for measurement of Residual Gastric Volume

The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.

Intervention Type PROCEDURE

Nasogastric Aspiration for Measurement of Gastric pH

The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Both male and female patients
2. Age between 1 to 12 years
3. Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia