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

• Sponsor: King Edward Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05922072
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Aspiration of Gastric Contents	Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume; Procedure: Nasogastric Aspiration for Measurement of Gastric pH	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 respectivelyTotal 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
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
• Actual Study Start Date: Jun 3, 2021
• Actual Primary Completion Date: Dec 3, 2021
• Actual Study Completion Date: Dec 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Long NPO group 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; The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.; 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.
Experimental: Short NPO group 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; The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.; 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.

Outcome Measures

Primary Outcome Measures

1. Mean residual gastric volume [6 Months]

   Mean Residual Gastric Volume will be measured in mililiter

Secondary Outcome Measures

1. Gastric pH [6 months]

   Gastric pH will be measured by pH Litmus paper

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 12 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paeds Surgery Department Mayo Hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• King Edward Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatima Numeri, Assistant Professor, King Edward Medical University
• ClinicalTrials.gov Identifier: NCT05922072
• Other Study ID Numbers: KingEdwarMU
• First Posted: Jun 28, 2023
• Last Update Posted: Jun 28, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Respiratory Aspiration of Gastric Contents

Study Results

No Results Posted as of Jun 28, 2023