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Propofol vs Remifentanil for Sedation in Gastroscopy

Comparison of Propofol and Remifentanil for Sedation in Elective Gastroscopy: A Prospective Randomized Study Evaluating Safety, Recovery Quality, and Endoscopist Satisfaction

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07336628
Acronym
ROPOGAST
Enrollment
80
Registered
2026-01-13
Start date
2026-02-02
Completion date
2026-04-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation, Procedural Sedation

Keywords

Procedural Sedation, Ramsay Sedation Scale, Awakening Time, Conscious Sedation, BIS Monitoring, Bispectral Index, Gastroscopy, Remifentanil, Propofol, Endoscopist Satisfaction, Recovery Quality, QoR-15

Brief 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. 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.

Interventions

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.

DRUGRemifentanil

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.

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

Two-arm parallel design with 1:1 randomization. No crossover.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery TimeFrom the end of the gastroscopy procedure until achievement of discharge criteria, assessed up to 2 hoursRecovery 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 ComplicationsFrom the start of sedation induction until discharge from the recovery area, assessed up to 2 hoursSedation-related complications include respiratory depression, hypoxia (oxygen saturation \<90%), bradycardia, hypotension, and the need for airway interventions or pharmacological support.

Secondary

MeasureTime frameDescription
Procedure DurationFrom insertion to removal of the endoscopeProcedure duration is defined as the time from endoscope insertion to removal.
Quality of Recovery (QoR-15 Score)At discharge from the recovery area, approximately 1-2 hours after the end of the procedurePatient-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.
Endoscopist SatisfactionImmediately after procedure completion, within 5 minutes of endoscope removalEndoscopist satisfaction with procedural conditions is assessed using a 5-point Likert scale, where higher scores indicate greater satisfaction.
Time to DischargeFrom completion of gastroscopy until discharge from the endoscopy unit, assessed up to 6 hours post-procedure.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).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORcansu ofluoglu, md

Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation

STUDY_DIRECTORdoga meric yukselen, md

Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026