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

Not Applicable

Completed

• Conditions: Pulmonary Aspiration of Gastric Contents
• Interventions: Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume; Procedure: Nasogastric Aspiration for Measurement of Gastric pH

• Registration Number: NCT05922072
• Lead Sponsor: King Edward Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-06-03
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Study First Submitted: 2023-03-07
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short NPO group	Nasogastric Aspiration for Measurement of Gastric pH	6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
Long NPO group	Nasogastric Aspiration for Measurement of Gastric pH	6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively
Long NPO group	Nasogastric aspiration for measurement of Residual Gastric Volume	6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively
Short NPO group	Nasogastric aspiration for measurement of Residual Gastric Volume	6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively

Primary Outcome Measures

Name	Time	Method
Mean residual gastric volume	6 Months	Mean Residual Gastric Volume will be measured in mililiter

Secondary Outcome Measures

Name	Time	Method
Gastric pH	6 months	Gastric pH will be measured by pH Litmus paper

Trial Locations

Locations (1)

Paeds Surgery Department Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan