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NCT Number: NCT07537582

Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort.

Gastric POCUS has been validated and shown to be an accurate diagnostic tool in both healthy individuals and medically complex patient populations. Regional anaesthesiologists and pain management physicians frequently provide sedation or anaesthetic care for medically complex patients who fall outside the limited applicability of existing fasting guidelines, including patients with chronic pain, poor acute-on-chronic pain control, and those receiving acute or chronic opioid therapy. These patients are at risk of delayed gastric emptying and may therefore benefit from additional pre-procedural assessment using gastric ultrasound prior to elective interventions

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danat Al Emarat Women & Children Hospital

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Location contact

JINAN JAMEEL AL ALOOSI, Consultant Anesthesiologist

CONTACT

[email protected]

+971507291195

JINAN JAMEEL AL ALOOSI, Consultant Anesthesiologist

PRINCIPAL_INVESTIGATOR

Waleed Riad, Pain medicine Anesthesiologist

CONTACT

[email protected]

+971525773423

Waleed Riad, Pain medicine Anesthesiologist

PRINCIPAL_INVESTIGATOR

About this study

This study is the first prospective evaluation of gastric ultrasound in this high-risk, understudied population, incorporating quantitative opioid exposure and focusing on its impact on real-time anaesthetic decision-making. By linking gastric ultrasound findings to changes in peri-procedural management, this work extends gastric POCUS from a diagnostic tool to a clinically actionable risk-stratification strategy.

The aim of this study is to determine whether pre-operative gastric POCUS provides decision-relevant information that influences peri-operative aspiration risk assessment and leads to modification of pre-defined anaesthetic management plans in chronic pain patients undergoing elective interventional procedures under sedation.

Pre-procedural gastric ultrasound will be performed immediately before initiation of sedation by the investigators experienced in gastric point-of-care ultrasound, each having completed at least 30 supervised examinations. A standardised scanning protocol was used. Qualitative assessment of gastric contents was performed in the supine position and in the right lateral decubitus position. When patient-related factors precluded these positions, scanning was performed in a semi-recumbent position at approximately 45°.

Gastric contents will be classified qualitatively as:

  • Empty
  • Fluid (homogeneous hypoechoic contents)
  • Solid or mixed (heterogeneous contents with echogenic material) When fluid content was identified, the gastric antral cross-sectional area (CSA) was measured at rest in a parasagittal plane at the level of the abdominal aorta using the serosal tracing method, as previously described. Gastric fluid volume was estimated using the validated Perlas mathematical model.

In accordance with current literature and consensus recommendations, patients with solid or mixed gastric contents were classified as having a high aspiration risk. For patients with fluid contents, a gastric volume threshold of >1.5 ml·kg-¹ body weight was used to define high aspiration risk. Patients with an empty stomach or fluid volumes ≤1.5 ml·kg-¹ were classified as low risk.

Following completion of gastric ultrasound and prior to initiation of sedation, the responsible anaesthetist reassessed the patient's aspiration risk incorporating the ultrasound findings. The anaesthetist documented whether the original anaesthetic management plan was:

  • Unchanged
  • Modified to a more conservative approach (additional measures to reduce aspiration risk)
  • Modified to a more liberal approach Anaesthetic management modifications were made at the discretion of the responsible anaesthesiologist to ensure patient safety. The anesthesiologist responsible for patient care will not be blinded to ultrasound findings, consistent with the observational nature of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients were eligible for inclusion if they met all of the following criteria:

  • Age ≥18 years
  • Scheduled for elective chronic pain interventional procedures under procedural sedation
  • Adherence to standard preoperative fasting guidelines (≥6 hours for clear fluids and ≥8 hours for solids)
  • Presence of at least one clinical factor associated with delayed gastric emptying or increased risk of pulmonary aspiration, including:
  • Chronic opioid use (≥2 weeks)
  • Acute opioid administration within 24 hours prior to the procedure
  • Poorly controlled acute-on-chronic pain
  • Diabetes mellitus without established autonomic neuropathy
  • Symptoms of gastroesophageal reflux
  • Reduced functional mobility
  • ASA physical status II-III

Exclusion criteria

Patients will be excluded if any of the following present:

  • Age <18 years
  • Previous gastric or esophageal surgery
  • Known pregnancy
  • Known hiatal hernia
  • Severe neurological disorders affecting swallowing or gastric motility
  • Established autonomic neuropathy affecting gastric emptying (e.g. advanced diabetic gastroparesis)
  • Morbid obesity (body mass index ≥35 kg·m-²), due to known limitations in gastric ultrasound image acquisition and reduced validity of volume estimation models
  • Inability to provide informed consent

Treatment and study plan

Primary outcomes

  1. The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan.

    Time frame: 1- 2 hours

    The Percentage of patients from the total number of patients involved in the study, in whom pre-procedural gastric ultrasound reveals signs of high aspiration risk which needed a change to the pre-defined anesthetic management plan, A management change was defined as any deviation from the originally documented sedation or airway strategy following review of ultrasound findings. (Patients with solid or mixed gastric contents, or fluid contents with a gastric volume of >1.5 ml·kg-¹ body weight are classified as having a high aspiration risk).

Secondary outcomes

  1. Prevalence of high-risk gastric contents despite adherence to fasting guidelines

    Time frame: 1- 2 hours

    Prevalence of number of patients in our study who were fasting in accordance with fasting guidelines, and in whom pre-procedural gastric ultrasound reveals solid / mixed gastric contents or a fluid content, with a gastric volume of >1.5 ml·kg-¹ body weight, which used to define a high aspiration risk.

  2. Associations between gastric ultrasound findings and patient-related factors, including opioid use and comorbidities

    Time frame: 1-2 hours

    To point out the effect and relation of each of the risk factors included in our study (e.g. Opioid use and comorbidities in chronic pain patients), on gastric contents & volume, in the studied patients after fasting period in accordance with fasting guidelines.

  3. Qualitative and quantitative gastric ultrasound findings

    Time frame: 1-2 hours

    To describe the gastric ultrasound finding; Gastric contents will be classified qualitatively as; Empty, Fluid (homogeneous hypoechoic contents), Solid or mixed (heterogeneous contents with echogenic material).

    Qualitative findings: When fluid content is identified, the gastric antral cross-sectional area (CSA) is measured at rest in a parasagittal plane at the level of the abdominal aorta. Gastric fluid volume is estimated using the validated Perlas mathematical model.

Study contacts

Contact information is provided by the study sponsor or research team.

JINAN JAMEEL AL ALOOSI, CONSULTANT ANESTHESIOLOGIST

CONTACT

[email protected]

+97150 7291195

Waleed Riad, Pain medicine Anesthesiologist

CONTACT

[email protected]

+97152 5773423

Sponsors and collaborators

Lead sponsor

Danat Al Emarat Hospital

Other

Registry information

Official study title

Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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