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NCT Number: NCT07017283

Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on on Perioperative Sedation Related Adverse Events in Elderly ERCP Patients

This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhijiang, 310016, China

Location status: Recruiting

Location contact

Xiaocui Lv

CONTACT

[email protected]

13567109477

About this study

This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 60 and above;
  • ASA physical status≤III;
  • Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system;
  • Willing to provide informed consent (or by legal guardian/witness if applicable).

Exclusion criteria

1: Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction; 2.Coagulopathy or epistaxis tendency; 3.Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias); 4.Pulmonary diseases (e.g., asthma, COPD); 5.Prior hypersensitivity to anesthetic agents; 6.Active upper respiratory infection; 7.Severe liver and kidney diseases; 8.Difficult airway: Preoperative anesthesiologist assessment of difficult airway; 9.Psychiatric disorders, cognitive impairment, critical illness, or pregnancy.

Treatment and study plan

Tracheal intubation general anesthesia

Device

Endotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure.

Nasopharyngeal airway ventilation

Device

Nasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure.

Primary outcomes

  1. Perioperative sedation related adverse events

    Time frame: Perioperative period

Secondary outcomes

  1. recovery room time

    Time frame: Perioperative period

  2. Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation

    Time frame: Perioperative

  3. Second intubation after the tracheal intubation is removed

    Time frame: Perioperative

  4. Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute)

    Time frame: Perioperative

  5. Rating of reflux degree

    Time frame: perioperative

  6. QoR-15 score on POD1

    Time frame: Postoperative day 1

  7. Incidence of postoperative nausea and vomiting

    Time frame: postoperative day 1

  8. respiratory failure/ARDS incidence

    Time frame: Perioperative

  9. Postoperative cognitive function assessment (MoCA)

    Time frame: Perioperative

    The Montreal Cognitive Assessment (MoCA) has a total score of 30 points, with a score of ≥26 considered normal

  10. patient/endoscopist satisfaction

    Time frame: Perioperative

    Patient/endoscopist satisfaction with sedation type was assessed using a 10-point visual analog scale (VAS), where 1 represented the worst possible experience and 10 indicated the optimal experience

  11. hospital stay duration

    Time frame: Perioperative

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Chen

CONTACT

[email protected]

Xiaocui Lv

CONTACT

[email protected]

+8613567109477

Sponsors and collaborators

Lead sponsor

Gang Chen

Other

Registry information

Official study title

Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on Perioperative Respiratory Adverse Events in Elderly ERCP Patients: An Open-Label Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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