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

K

King Edward Medical University

Status

Completed

Conditions

Pulmonary Aspiration of Gastric Contents

Treatments

Procedure: Nasogastric Aspiration for Measurement of Gastric pH
Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume

Study type

Interventional

Funder types

Other

Identifiers

NCT05922072
KingEdwarMU

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

1 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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