Propofol vs Remifentanil for Sedation in Gastroscopy (ROPOGAST)

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.

Study Overview

• Status: Completed
• Conditions: Procedural Sedation; Conscious Sedation
• Intervention / Treatment: Drug: Propofol (Astra-Zeneca); Drug: Remifentanil

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• ASA physical status I-III
• Scheduled for elective diagnostic gastroscopy
• Able to provide informed consent

Exclusion Criteria:

• 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
• Obstructive sleep apnea requiring CPAP
• Severe hepatic or renal impairment
• Inability to provide informed consent
• Emergency procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol Group; 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); 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.; Other Names: Propofol Injectable Emulsion
Active Comparator: Remifentanil Group; 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; 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.; Other Names: Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discharge Readiness	Time from procedure completion to achievement of Modified Aldrete Score ≥9, indicating readiness for discharge from the endoscopy unit. The Modified Aldrete Score assesses activity, respiration, circulation, consciousness, and oxygen saturation (0-10 scale, ≥9 required for discharge). Measured in minutes.	From end of procedure until discharge readiness, assessed up to 2 hours

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Principal Investigator: cansu ofluoglu, md, Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation; Study Director: doga meric yukselen, md, Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Remifentanil; Propofol; Gastroscopy; Conscious Sedation; QoR-15; Bispectral Index; Procedural Sedation; Recovery Quality; Ramsay Sedation Scale; Awakening Time; BIS Monitoring; Endoscopist Satisfaction
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Propionates; Remifentanil; Propofol
• Other Study ID Numbers: FSMTRHSEDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No