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ACTIVE NOT RECRUITING
NCT07336628
NA

Propofol vs Remifentanil for Sedation in Gastroscopy

Sponsor: Fatih Sultan Mehmet Training and Research Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-11-01

Completion Date

2026-04-01

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)