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

NCT07613073 | Not Yet Recruiting

• 1 other identifier: BMH-GI-PROPOFOL-OBS-2026-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension; Hypoxemia

Keywords

Propofol sedation; Gastrointestinal endoscopy; Colonoscopy; Upper gastrointestinal endoscopy; Oxygen desaturation; Hemodynamic instability; Prospective cohort; Procedural sedation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Clinically Relevant Hypotension

  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.

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

• Number of Participants With Clinically Relevant Hypoxemia

  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: 1. oxygen saturation (SpO2) \<90% for at least 10 seconds; or 2. any SpO2 \<85%; or 3. 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.

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

Secondary Outcomes (4)

• Number of participants with Severe hypotension

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

• Number of participants with severe hypoxemia

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

• Number of Participants Requiring Airway Intervention

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

• Vasopressor use

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

Other Outcomes (1)

• Time to Discharge From the Recovery Area

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

Study Arms (1)

Cohort Description

Adult patients undergoing diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy with propofol as the primary sedative/anesthetic agent at a tertiary referral hospital. All enrolled participants will receive standard peri-procedural monitoring and will be followed from pre-sedation assessment through discharge from the recovery area. If early post-procedure observation is prolonged because of a sedation-related cardiopulmonary event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.

Drug: Propofol; Procedure: Diagnostic gastrointestinal endoscopy

Interventions

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.

Cohort Description

Diagnostic gastrointestinal endoscopy PROCEDURE

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

Cohort Description

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bach Mai Hospital: lead

Study Sites (1)

Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Hypotension; Hypoxia

Interventions

Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Thang Toan Nguyen, PhD

CONTACT

+084916874795; nguyentoanthang@hmu.edu.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 29, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-04

Locations

VN (1)