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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05922072
Enrollment
120
Registered
2023-06-28
Start date
2021-06-03
Completion date
2021-12-03
Last updated
2023-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Aspiration of Gastric Contents

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.

Interventions

PROCEDURENasogastric 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.

PROCEDURENasogastric 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.

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean residual gastric volume6 MonthsMean Residual Gastric Volume will be measured in mililiter

Secondary

MeasureTime frameDescription
Gastric pH6 monthsGastric pH will be measured by pH Litmus paper

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026