Health TrialsbyHealthPanel

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

ConditionsBiliary and Pancreatic DiseasesEndoscopic Retrograde Cholangiopancreatography (ERCP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorGang Chen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: General anesthesiaActive comparator 1 intervention
Group B: Deep sedationExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gang Chen

Lead sponsor

Sir Run Run Shaw Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now