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
About this trial
This is an interventional prevention trial for Pulmonary Aspiration of Gastric Contents
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.
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
NCT ID
NCT05922072
First Posted
March 7, 2023
Last Updated
June 18, 2023
Sponsor
King Edward Medical University
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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