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

NCT05922072 | Completed DMC

• 1 other identifier: KingEdwarMU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Aspiration of Gastric Contents

Outcome Measures

Primary Outcomes (1)

• Mean residual gastric volume

  Mean Residual Gastric Volume will be measured in mililiter

  6 Months

Secondary Outcomes (1)

• Gastric pH

  6 months

Study Arms (2)

Long NPO group

ACTIVE COMPARATOR

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; Procedure: Nasogastric Aspiration for Measurement of Gastric pH

Short NPO group

EXPERIMENTAL

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; Procedure: Nasogastric Aspiration for Measurement of Gastric pH

Interventions

Nasogastric aspiration for measurement of Residual Gastric Volume PROCEDURE

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

Long NPO group; Short NPO group

Nasogastric Aspiration for Measurement of Gastric pH PROCEDURE

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

Long NPO group; Short NPO group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Paeds Surgery Department Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: June 28, 2023
• Study Start: June 3, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

PA (1)