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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol (Astra-Zeneca) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From the start of sedation induction until discharge from the recovery area, assessed up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | Procedure duration is defined as the time from endoscope insertion to removal. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| cansu ofluoglu, md | Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation | Principal Investigator |
| doga meric yukselen, md | Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital | Istanbul | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Two-arm parallel design with 1:1 randomization. No crossover.
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Participants are sedated during the procedure and unaware of group assignment. Outcomes assessors (recovery room nurses, independent observers assessing Ramsay scores) are blinded to group allocation. The anesthesiologist administering sedation is necessarily unblinded to allow appropriate drug titration but does not participate in outcome assessment. Endoscopists are blinded to group allocation and BIS values.
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| Remifentanil | Drug | 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. |
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| 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. | 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). | From completion of gastroscopy until discharge from the endoscopy unit, assessed up to 6 hours post-procedure. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |