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

Primary Purpose

Pulmonary Aspiration of Gastric Contents

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nasogastric aspiration for measurement of Residual Gastric Volume
Nasogastric Aspiration for Measurement of Gastric pH
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Aspiration of Gastric Contents

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paeds Surgery Department Mayo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Long NPO group

Short NPO group

Arm Description

6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively

6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively

Outcomes

Primary Outcome Measures

Mean residual gastric volume
Mean Residual Gastric Volume will be measured in mililiter

Secondary Outcome Measures

Gastric pH
Gastric pH will be measured by pH Litmus paper

Full Information

First Posted
March 7, 2023
Last Updated
June 18, 2023
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05922072
Brief Title
Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
Official Title
Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Aspiration of Gastric Contents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long NPO group
Arm Type
Active Comparator
Arm Description
6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively
Arm Title
Short NPO group
Arm Type
Experimental
Arm Description
6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
Intervention Type
Procedure
Intervention Name(s)
Nasogastric aspiration for measurement of Residual Gastric Volume
Intervention Description
The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.
Intervention Type
Procedure
Intervention Name(s)
Nasogastric Aspiration for Measurement of Gastric pH
Intervention Description
The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.
Primary Outcome Measure Information:
Title
Mean residual gastric volume
Description
Mean Residual Gastric Volume will be measured in mililiter
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Gastric pH
Description
Gastric pH will be measured by pH Litmus paper
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.
Facility Information:
Facility Name
Paeds Surgery Department Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

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

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