Conscious SedationROPOGASTNCT07336628
Propofol vs Remifentanil for Sedation in Gastroscopy
A study testing Propofol (Astra-Zeneca) and Remifentanil in people with Conscious Sedation and Procedural Sedation, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized study aims to compare propofol and remifentanil for sedation during elective diagnostic gastroscopy. The ideal sedative agent for gastroscopy should provide adequate sedation, rapid recovery, patient safety, and high endoscopist satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conscious Sedation, Procedural Sedation
- What is being tested?
- Propofol (Astra-Zeneca) and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age ≥18 years
- ASA physical status I-III
- Scheduled for elective diagnostic gastroscopy
- Able to provide informed consent
Who cannot join
- ASA IV-V
- Pregnancy or lactation
- Known allergy to propofol, remifentanil, or midazolam
- Severe cardiopulmonary disease (NYHA III-IV, unstable angina, severe COPD requiring home oxygen)
- Chronic opioid use (>3 months daily use)
- BMI >40 kg/m²
Show all 10Show fewer
- Obstructive sleep apnea requiring CPAP
- Severe hepatic or renal impairment
- Inability to provide informed consent
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Propofol and Remifentanil for Sedation in Elective Gastroscopy: A Prospective Randomized Study Evaluating Safety, Recovery Quality, and Endoscopist Satisfaction
This prospective randomized study aims to compare propofol and remifentanil for sedation during elective diagnostic gastroscopy. The ideal sedative agent for gastroscopy should provide adequate sedation, rapid recovery, patient safety, and high endoscopist satisfaction. Although propofol is widely used for procedural sedation, remifentanil's ultra-short pharmacokinetic profile may offer advantages in short procedures such as gastroscopy. However, comprehensive comparative data evaluating recovery quality, safety, and procedural conditions between these agents remain limited. This study evaluates sedation efficacy, recovery characteristics, complication rates, and endoscopist satisfaction associated with propofol- and remifentanil-based sedation protocols.
Read the detailed description
Gastroscopy is a commonly performed diagnostic procedure that often requires sedation to improve patient comfort and procedural conditions. The choice of sedative agent plays a critical role in balancing procedural efficacy, patient safety, rapid recovery, and endoscopist satisfaction. Propofol is frequently preferred due to its rapid onset and predictable recovery profile; however, it is associated with dose-dependent respiratory and hemodynamic adverse effects. Remifentanil, an ultra-short-acting opioid, offers rapid titratability and fast recovery, potentially making it an attractive alternative for short-duration procedures such as gastroscopy.
This prospective randomized study was conducted between October 2025 and January 2026 and included 86 adult patients with American Society of Anesthesiologists (ASA) physical status I-III who were scheduled for elective diagnostic gastroscopy. Patients were randomly assigned using block randomization to receive either propofol-based sedation (n=44) or remifentanil-based sedation (n=42). All patients received 2 mg intravenous midazolam as premedication prior to the procedure.
In the propofol group, sedation was maintained using a continuous infusion of propofol at 100-150 mcg/kg/min. In the remifentanil group, patients received a loading dose of 1 mcg/kg followed by a continuous infusion of 0.025-0.1 mcg/kg/min. Sedation depth was standardized and continuously monitored using bispectral index (BIS), targeting values between 60 and 80, in combination with the Ramsay Sedation Scale, targeting scores of 2-3.
The primary outcome measures were recovery time and the incidence of sedation-related complications, including respiratory depression, hypoxia, bradycardia, hypotension, and the need for airway interventions. Secondary outcome measures included procedure duration, patient-reported quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire (score range 0-75), endoscopist satisfaction measured using a 5-point Likert scale, and time to discharge.
By comparing these two sedation strategies under standardized monitoring and sedation targets, this study aims to provide clinically relevant evidence to guide sedative agent selection for elective gastroscopy, focusing on recovery quality, safety profile, and procedural satisfaction.
- Conditions
- Conscious Sedation, Procedural Sedation
- Being tested
- Propofol (Astra-Zeneca), Remifentanil
- Keywords
- Procedural Sedation, Ramsay Sedation Scale, Awakening Time, Conscious Sedation, BIS Monitoring, Bispectral Index, Gastroscopy, Remifentanil, Propofol, Endoscopist Satisfaction, Recovery Quality, QoR-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol (Astra-Zeneca)Drug
Also called Propofol Injectable Emulsion
Continuous intravenous infusion of propofol at 100-150 µg/kg/min, titrated to maintain bispectral index (BIS) values between 60 and 80 and Ramsay Sedation Scale scores of 2-3. Infusion is initiated after endoscopy team confirms readiness and continued until procedure completion. Administered only to participants in the Propofol Group.
RemifentanilDrug
Also called Ultiva
Intravenous loading dose of remifentanil 1 µg/kg administered over 60 seconds, followed by continuous infusion at 0.025-0.1 µg/kg/min. Infusion rate is titrated to maintain bispectral index (BIS) values between 60 and 80 and Ramsay Sedation Scale scores of 2-3. Infusion is initiated after endoscopy team confirms readiness and continued until procedure completion. Administered only to participants in the Remifentanil Group.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Active comparator | Patients receive midazolam 2 mg IV premedication followed by continuous propofol infusion (100-150 µg/kg/min) titrated to maintain BIS 60-80. Receives: Drug: Propofol (Astra-Zeneca) |
| Remifentanil Group | Active comparator | Patients receive midazolam 2 mg IV premedication followed by remifentanil loading dose (1 µg/kg) and continuous infusion (0.025-0.1 µg/kg/min) titrated to maintain BIS 60-80. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Time
Recovery time is defined as the time interval from completion of the gastroscopy procedure to achievement of predefined discharge criteria in the recovery area.
Measured: From the end of the gastroscopy procedure until achievement of discharge criteria, assessed up to 2 hours
Incidence of Sedation-Related Complications
Sedation-related complications include respiratory depression, hypoxia (oxygen saturation <90%), bradycardia, hypotension, and the need for airway interventions or pharmacological support.
Measured: From the start of sedation induction until discharge from the recovery area, assessed up to 2 hours
Secondary outcomes (4)
Procedure Duration
Procedure duration is defined as the time from endoscope insertion to removal.
Measured: From insertion to removal of the endoscope
Quality of Recovery (QoR-15 Score)
Patient-reported quality of recovery is assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with scores ranging from 0 to 75, where higher scores indicate better recovery quality.
Measured: At discharge from the recovery area, approximately 1-2 hours after the end of the procedure
Endoscopist Satisfaction
Endoscopist satisfaction with procedural conditions is assessed using a 5-point Likert scale, where higher scores indicate greater satisfaction.
Measured: Immediately after procedure completion, within 5 minutes of endoscope removal
Time to Discharge
Time to discharge is defined as the interval, measured in minutes, from completion of the gastroscopy procedure to actual discharge from the endoscopy unit according to institutional discharge criteria. Shorter time indicates faster recovery (better outcome).
Measured: From completion of gastroscopy until discharge from the endoscopy unit, assessed up to 6 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Feb 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel design with 1:1 randomization. No crossover.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Ofluoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- cansu ofluoglu, md, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimationdoga meric yukselen, md, Study director, Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336628
- Sponsor's protocol ID
- FSMTRHSEDO
- Acronym
- ROPOGAST
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality in accordance with local data protection regulations and institutional ethics committee requirements. Summary results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol and Remifentanil for Sedation in Elective Gastroscopy: A Prospective Randomized Study Evaluating Safety, Recovery Quality, and Endoscopist Satisfaction
- ClinicalTrials.gov ID
- NCT07336628
- Acronym / sponsor ID
- ROPOGAST / FSMTRHSEDO
- Conditions
- Conscious Sedation, Procedural Sedation
- Keywords
- Procedural Sedation, Ramsay Sedation Scale, Awakening Time, Conscious Sedation, BIS Monitoring, Bispectral Index, Gastroscopy, Remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 13 Jan 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 randomized study aims to compare propofol and remifentanil for sedation during elective diagnostic gastroscopy. The ideal sedative agent for gastroscopy should provide adequate sedation, rapid recovery, patient safety, and high endoscopist satisfaction. Although propofol is widely used for procedural sedation, remifentanil's ultra-short pharmacokinetic profile may offer advantages in short procedures such as gastroscopy. However, comprehensive comparative data evaluating recovery quality, safety, and procedural conditions between these agents remain limited. This study evaluates sedation efficacy, recovery characteristics, complication rates, and endoscopist satisfaction associated with propofol- and remifentanil-based sedation protocols.
Detailed description
Gastroscopy is a commonly performed diagnostic procedure that often requires sedation to improve patient comfort and procedural conditions. The choice of sedative agent plays a critical role in balancing procedural efficacy, patient safety, rapid recovery, and endoscopist satisfaction. Propofol is frequently preferred due to its rapid onset and predictable recovery profile; however, it is associated with dose-dependent respiratory and hemodynamic adverse effects. Remifentanil, an ultra-short-acting opioid, offers rapid titratability and fast recovery, potentially making it an attractive alternative for short-duration procedures such as gastroscopy.
This prospective randomized study was conducted between October 2025 and January 2026 and included 86 adult patients with American Society of Anesthesiologists (ASA) physical status I-III who were scheduled for elective diagnostic gastroscopy. Patients were randomly assigned using block randomization to receive either propofol-based sedation (n=44) or remifentanil-based sedation (n=42). All patients received 2 mg intravenous midazolam as premedication prior to the procedure.
In the propofol group, sedation was maintained using a continuous infusion of propofol at 100-150 mcg/kg/min. In the remifentanil group, patients received a loading dose of 1 mcg/kg followed by a continuous infusion of 0.025-0.1 mcg/kg/min. Sedation depth was standardized and continuously monitored using bispectral index (BIS), targeting values between 60 and 80, in combination with the Ramsay Sedation Scale, targeting scores of 2-3.
The primary outcome measures were recovery time and the incidence of sedation-related complications, including respiratory depression, hypoxia, bradycardia, hypotension, and the need for airway interventions. Secondary outcome measures included procedure duration, patient-reported quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire (score range 0-75), endoscopist satisfaction measured using a 5-point Likert scale, and time to discharge.
By comparing these two sedation strategies under standardized monitoring and sedation targets, this study aims to provide clinically relevant evidence to guide sedative agent selection for elective gastroscopy, focusing on recovery quality, safety profile, and procedural satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel design with 1:1 randomization. No crossover.
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Active comparator | Drug: Propofol (Astra-Zeneca)Patients receive midazolam 2 mg IV premedication followed by continuous propofol infusion (100-150 µg/kg/min) titrated to maintain BIS 60-80. |
| Remifentanil Group | Active comparator | Drug: RemifentanilPatients receive midazolam 2 mg IV premedication followed by remifentanil loading dose (1 µg/kg) and continuous infusion (0.025-0.1 µg/kg/min) titrated to maintain BIS 60-80. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- ASA physical status I-III
- Scheduled for elective diagnostic gastroscopy
- Able to provide informed consent
Key exclusion criteria (10 listed)
- ASA IV-V
- Pregnancy or lactation
- Known allergy to propofol, remifentanil, or midazolam
- Severe cardiopulmonary disease (NYHA III-IV, unstable angina, severe COPD requiring home oxygen)
- Chronic opioid use (>3 months daily use)
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 |
|---|---|---|
| Propofol (Astra-Zeneca)Also: Propofol Injectable EmulsionContinuous intravenous infusion of propofol at 100-150 µg/kg/min, titrated to maintain bispectral index (BIS) values between 60 and 80 and Ramsay Sedation Scale scores of 2-3. Infusion is initiated after endoscopy team confirms readiness and continued until procedure completion. Administered only to participants in the Propofol Group. | Drug | Propofol Group |
| RemifentanilAlso: UltivaIntravenous loading dose of remifentanil 1 µg/kg administered over 60 seconds, followed by continuous infusion at 0.025-0.1 µg/kg/min. Infusion rate is titrated to maintain bispectral index (BIS) values between 60 and 80 and Ramsay Sedation Scale scores of 2-3. Infusion is initiated after endoscopy team confirms readiness and continued until procedure completion. Administered only to participants in the Remifentanil Group. | Drug | Remifentanil Group |
Primary outcome
Recovery Time
Time frame: From the end of the gastroscopy procedure until achievement of discharge criteria, assessed up to 2 hours
Recovery time is defined as the time interval from completion of the gastroscopy procedure to achievement of predefined discharge criteria in the recovery area.
Incidence of Sedation-Related Complications
Time frame: From the start of sedation induction until discharge from the recovery area, assessed up to 2 hours
Sedation-related complications include respiratory depression, hypoxia (oxygen saturation <90%), bradycardia, hypotension, and the need for airway interventions or pharmacological support.
4 secondary outcomes
Procedure Duration
Time frame: From insertion to removal of the endoscope
Quality of Recovery (QoR-15 Score)
Time frame: At discharge from the recovery area, approximately 1-2 hours after the end of the procedure
Endoscopist Satisfaction
Time frame: Immediately after procedure completion, within 5 minutes of endoscope removal
Time to Discharge
Time frame: From completion of gastroscopy until discharge from the endoscopy unit, assessed up to 6 hours post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality in accordance with local data protection regulations and institutional ethics committee requirements. Summary results will be published in peer-reviewed journals.
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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. This study is not recruiting at the moment.
cansu ofluoglu, md principal investigator
Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation
doga meric yukselen, md study director
Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol (Astra-Zeneca) and Remifentanil in people with Conscious Sedation and Procedural Sedation, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 21 Apr 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery Time (time frame: From the end of the gastroscopy procedure until achievement of discharge criteria, assessed up to 2 hours). 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 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.