Propofol vs Remifentanil for Sedation in Gastroscopy

NCT07336628 | Completed

• 1 other identifier: FSMTRHSEDO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Procedure Duration

  From insertion to removal of the endoscope

• Quality of Recovery (QoR-15 Score)

  At discharge from the recovery area, approximately 1-2 hours after the end of the procedure

• Endoscopist Satisfaction

  Immediately after procedure completion, within 5 minutes of endoscope removal

• Time to Discharge

  From completion of gastroscopy until discharge from the endoscopy unit, assessed up to 6 hours post-procedure.

Study Arms (2)

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.

Drug: Propofol (Astra-Zeneca)

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.

Drug: Remifentanil

Interventions

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.

Also known as: Propofol Injectable Emulsion

Propofol Group

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.

Also known as: Ultiva

Remifentanil Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

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

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: February 2, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)