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

Gang Chen170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Biliary and Pancreatic Diseases Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

Tracheal intubation general anesthesiaDEVICE

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

Nasopharyngeal airway ventilationDEVICE

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion criteria： 1. Aged 60 and above; 2. ASA physical status≤III; 3. Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system; 4. 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.

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhijiang, China

RECRUITING

Outcomes

Primary Outcomes

Perioperative sedation related adverse events

Time frame: Perioperative period

Secondary Outcomes

recovery room time

Time frame: Perioperative period

Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation

Time frame: Perioperative

Second intubation after the tracheal intubation is removed

Time frame: Perioperative

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

Time frame: Perioperative

Rating of reflux degree

Time frame: perioperative

QoR-15 score on POD1

Time frame: Postoperative day 1

Incidence of postoperative nausea and vomiting

Time frame: postoperative day 1

respiratory failure/ARDS incidence

Time frame: Perioperative

Postoperative cognitive function assessment (MoCA)

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

Time frame: Perioperative

patient/endoscopist satisfaction

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

Central Contacts

Xiaocui Lv

CONTACT

+8613567109477 3412008@zju.edu.cn

Gang Chen

CONTACT

chengang120@zju.edu.cn

Data from ClinicalTrials.gov

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