Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective Surgery

• Sponsor: Mahidol University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04664751
• Collaborator: (none)
• Enrollment: 304
• Location: 1
• Anticipated Duration (Months): 23.2
• Patients Per Site Per Month: 13.1

Study Details

Study Description

Brief Summary

Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having

• clear liquid drink

• light meal

• regular meal

Condition or Disease	Intervention/Treatment	Phase
Compliance, Treatment	Other: Nil-per-Oral

Study Design

• Study Type: Observational
• Anticipated Enrollment: 304 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective General Surgery.
• Actual Study Start Date: Dec 26, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients scheduled for general surgery with anesthesia Patients scheduled for general surgery with anesthesia, receiving Nil-per-Oral order.	Other: Nil-per-Oral; NPO details

Outcome Measures

Primary Outcome Measures

1. compliance to NPO guideline [8 hour]

   definition of compliance include complete order of NPO for regular diet for 8 hours and soft diet for 6 hours and clear liquid for 2 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia.

Exclusion Criteria:

• Patients with the order of NPO after midnight.

• Patients with pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Sirilak Suksompong, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
• ClinicalTrials.gov Identifier: NCT04664751
• Other Study ID Numbers: 997/2563(IRB2)
• First Posted: Dec 11, 2020
• Last Update Posted: Jun 2, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sirilak Suksompong, Associate Professor, Mahidol University: Compliance; NPO guidelines

Study Results

No Results Posted as of Jun 2, 2022