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NCT Number: NCT07613073

Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy

This prospective observational cohort study will evaluate the incidence and independent predictors of clinically relevant hypotension and hypoxemia during propofol-based diagnostic gastrointestinal endoscopy in adult patients at a tertiary referral hospital in Vietnam. Participants undergoing diagnostic upper gastrointestinal endoscopy, colonoscopy, or combined diagnostic procedures with propofol administration will be followed from pre-procedure assessment through the early recovery period. The study will assess demographic, clinical, airway, procedural, and sedation-related variables associated with clinically relevant cardiopulmonary adverse events.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital

Hanoi, Vietnam

Location contact

Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.

CONTACT

[email protected]

+084869587720

About this study

Propofol is widely used for diagnostic gastrointestinal endoscopy because of its rapid onset and recovery profile, but it may be associated with cardiopulmonary adverse events, particularly hypotension and hypoxemia. The reported incidence of these events varies substantially across studies because of differences in patient populations, definitions, monitoring intensity, and sedation/anesthesia practice.

This single-center prospective cohort study will enroll adult patients undergoing diagnostic gastrointestinal endoscopy with propofol as the primary sedative/anesthetic agent. Eligible participants will be consecutively recruited at Bach Mai Hospital. Baseline demographic characteristics, comorbidities, airway assessment findings, obstructive sleep apnea risk, procedural characteristics, and sedation/anesthesia-related variables will be collected using a standardized case report form.

The two co-primary outcomes are clinically relevant hypotension and clinically relevant hypoxemia during the peri-procedural period. Participants will be monitored from pre-procedure baseline through the procedure and until discharge from the recovery area. If early post-procedure observation is prolonged because of a sedation/anesthesia-related event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.

Two separate multivariable logistic regression models will be developed to identify independent predictors of clinically relevant hypotension and clinically relevant hypoxemia. The study is intended to inform risk stratification and improve patient safety during propofol-based diagnostic gastrointestinal endoscopy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Scheduled for diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy
  • Planned use of propofol as the primary sedative/anesthetic agent for diagnostic gastrointestinal endoscopy
  • American Society of Anesthesiologists physical status I to III
  • Able to provide informed consent or has legally authorized representative consent according to local regulations

Exclusion criteria

  • Therapeutic or interventional gastrointestinal endoscopy, including ERCP, EUS-guided intervention, EMR, ESD, endoscopic hemostasis, or polypectomy
  • Planned sedation/anesthesia without propofol as the primary sedative/anesthetic agent
  • Known allergy or contraindication to propofol
  • Pregnancy or suspected pregnancy
  • Emergency condition requiring immediate advanced airway control before the procedure
  • Inability to obtain essential baseline or outcome data required for the study

Treatment and study plan

Propofol

Drug

Propofol is the primary sedative/anesthetic agent used for diagnostic gastrointestinal endoscopy according to routine clinical practice. The loading dose, incremental bolus doses, maintenance infusion rate if used, total dose, weight-normalized total dose, timing of administration, and any adjunct sedative or analgesic medications will be recorded as observational exposure variables.

Diagnostic gastrointestinal endoscopy

Procedure

Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.

Primary outcomes

  1. Number of Participants With Clinically Relevant Hypotension

    Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

    Number of participants with clinically relevant hypotension during propofol-based diagnostic gastrointestinal endoscopy. Clinically relevant hypotension should be defined according to the protocol-specified blood pressure threshold and duration.

  2. Number of Participants With Clinically Relevant Hypoxemia

    Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

    Number of participants with clinically relevant hypoxemia during propofol-based diagnostic gastrointestinal endoscopy. Clinically relevant hypoxemia should be defined according to the protocol-specified oxygen saturation threshold and duration. Clinically relevant hypoxemia is defined as at least one of the following during the peri-procedural period:

    • oxygen saturation (SpO2) <90% for at least 10 seconds; or
    • any SpO2 <85%; or
    • hypoxemia requiring airway or respiratory intervention, including head repositioning, chin lift, jaw thrust, increased oxygen flow, oral/nasal airway placement, bag-mask ventilation, or temporary interruption of the procedure.

Secondary outcomes

  1. Number of participants with Severe hypotension

    Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

    Number of participants with Severe hypotension, Severe hypotension is defined as mean arterial pressure <60 mmHg or systolic blood pressure <80 mmHg.

  2. Number of participants with severe hypoxemia

    Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

    Number of participants with severe hypoxemia. Severe hypoxemia is defined as any oxygen saturation <85%.

  3. Number of Participants Requiring Airway Intervention

    Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

    Number of participants who require any airway intervention, including head repositioning, chin lift, jaw thrust, oral or nasal airway insertion, bag-mask ventilation, or tracheal intubation.

  4. Vasopressor use

    Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

    Administration of vasopressor medication to treat peri-procedural hypotension.

Other outcomes

  1. Time to Discharge From the Recovery Area

    Time frame: From end of procedure to discharge from the recovery area, assessed up to 4 hours.

    Time from end of procedure to discharge from the recovery area.

Study contacts

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

Thang Toan Nguyen, PhD

CONTACT

[email protected]

+084916874795

Sponsors and collaborators

Lead sponsor

Bach Mai Hospital

Other

Registry information

Official study title

Independent Predictors of Clinically Relevant Hypotension and Hypoxemia During During Propofol-Based Diagnostic Gastrointestinal Endoscopy: A Prospective Cohort Study

Acronym: PRO-GI SAFE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 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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