An interventional study of Propofol (Astra-Zeneca) and Remifentanil in Conscious Sedation and Procedural Sedation, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Not applicable, Interventional, and Supportive care
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.
Fatih Sultan Mehmet Training and Research Hospital is the lead sponsor of 118 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive midazolam 2 mg IV premedication followed by continuous propofol infusion (100-150 µg/kg/min) titrated to maintain BIS 60-80.
Drug: Propofol (Astra-Zeneca)
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.
Drug: Remifentanil
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.
Also known as: Propofol Injectable Emulsion
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.
Also known as: Ultiva
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.
Time frame: 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.
Time frame: From the start of sedation induction until discharge from the recovery area, assessed up to 2 hours
Procedure Duration
Procedure duration is defined as the time from endoscope insertion to removal.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From completion of gastroscopy until discharge from the endoscopy unit, assessed up to 6 hours post-procedure.
Plan to share: 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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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Fatih Sultan Mehmet Training and Research Hospital