An observational study in Hypotension and Hypoxemia, sponsored by Bach Mai Hospital. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Bach Mai Hospital · Observational
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.
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
Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.
Exclusion Criteria:
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
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 includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.
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.
Time frame: 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.
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Number of participants with Severe hypotension
Number of participants with Severe hypotension, Severe hypotension is defined as mean arterial pressure \<60 mmHg or systolic blood pressure \<80 mmHg.
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Number of participants with severe hypoxemia
Number of participants with severe hypoxemia. Severe hypoxemia is defined as any oxygen saturation \<85%.
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Number of Participants Requiring Airway Intervention
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.
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Vasopressor use
Administration of vasopressor medication to treat peri-procedural hypotension.
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Time to Discharge From the Recovery Area
Time from end of procedure to discharge from the recovery area.
Time frame: From end of procedure to discharge from the recovery area, assessed up to 4 hours.
Plan to share: Undecided — The investigators have not yet finalized a plan for sharing individual participant data. Any future decision will be subject to institutional approval, participant confidentiality safeguards, applicable ethics requirements, and journal or data-sharing policies in effect at the time of publication.
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Bach Mai Hospital