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临床试验/NCT07336628
NCT07336628
已完成
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Comparison of Propofol and Remifentanil for Sedation in Elective Gastroscopy: A Prospective Randomized Study Evaluating Safety, Recovery Quality, and Endoscopist Satisfaction

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月2日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Fatih Sultan Mehmet Training and Research Hospital
入组人数
80
试验地点
1
主要终点
Recovery Time

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Propofol (Astra-Zeneca) (Drug)

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.

干预措施: Remifentanil (Drug)

结局指标

主要结局

Recovery Time

时间窗: From the end of the gastroscopy procedure until achievement of discharge criteria, assessed up to 2 hours

Recovery 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 Complications

时间窗: From the start of sedation induction until discharge from the recovery area, assessed up to 2 hours

Sedation-related complications include respiratory depression, hypoxia (oxygen saturation \<90%), bradycardia, hypotension, and the need for airway interventions or pharmacological support.

次要结局

  • 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.)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cansu Ofluoğlu

Specialist in Anesthesiology and Reanimation

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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