HypotensionPRO-GI SAFENCT07613073
Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy
An observational study of Hypotension and Hypoxemia, run by Bach Mai Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Hypoxemia
- What is being tested?
- Propofol and Diagnostic gastrointestinal endoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteVietnam
- Study dates
- 15 May 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
Hanoi
Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital., +084869587720, trungtamgaymehoisuc@bachmai.edu.vn
About this study
Official title: Independent Predictors of Clinically Relevant Hypotension and Hypoxemia During During Propofol-Based Diagnostic Gastrointestinal Endoscopy: A Prospective Cohort Study
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.
Read the detailed description
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
- Conditions
- Hypotension, Hypoxemia
- Being tested
- Propofol, Diagnostic gastrointestinal endoscopy
- Keywords
- Propofol sedation, Gastrointestinal endoscopy, Colonoscopy, Upper gastrointestinal endoscopy, Oxygen desaturation, Hemodynamic instability, Prospective cohort, Procedural sedation
- Medical subject headings
- Hypotension, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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 endoscopyProcedure or surgery
Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propofol; Procedure: Diagnostic gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Secondary outcomes (4)
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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 May 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Toan Thang, Bach Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613073
- Sponsor's protocol ID
- BMH-GI-PROPOFOL-OBS-2026-01
- Acronym
- PRO-GI SAFE
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Predictors of Clinically Relevant Hypotension and Hypoxemia During During Propofol-Based Diagnostic Gastrointestinal Endoscopy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07613073
- Acronym / sponsor ID
- PRO-GI SAFE / BMH-GI-PROPOFOL-OBS-2026-01
- Conditions
- Hypotension, Hypoxemia
- Keywords
- Propofol sedation, Gastrointestinal endoscopy, Colonoscopy, Upper gastrointestinal endoscopy, Oxygen desaturation, Hemodynamic instability, Prospective cohort, Procedural sedation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bach Mai HospitalUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Description | – | Drug: Propofol, Procedure: Diagnostic gastrointestinal endoscopyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol 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. | Drug | Cohort Description |
| Diagnostic gastrointestinal endoscopyDiagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention. | Procedure or surgery | Cohort Description |
Primary outcome
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.
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: 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.
4 secondary outcomes
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 hypoxemia
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Number of Participants Requiring Airway Intervention
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Vasopressor use
Time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Hypoxemia, run by Bach Mai Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thang Toan Nguyen, PhD (+084916874795, nguyentoanthang@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Relevant Hypotension (time frame: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.