Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBach Mai Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Propofol
DrugPropofol 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/SurgeryDiagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Cohort Description2 interventions
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov
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