Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients

ConditionAnesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorBeijing Friendship Hospital

About this trial

This study aims to compare the effects of conscious sedation and intravenous general anesthesia on cardiovascular events in frail patients undergoing digestive endoscopy diagnosis and treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than 65 years old, regardless of gender

ASA is classified as Class II and III;

BMI 18-28 kg/m2;

Patients undergoing examination or treatment outside the operating room;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • The conscious sedation group

    Procedure/Surgery

    The conscious sedation group (Group A) received sufentanil 0.05-0.1 5 minutes before examination μ G/kg, administration time 30 seconds, 1-2 mg of midazolam administered 2 minutes before examination; Evaluate the patient's MOAA/S score, insert a digestive endoscope at 2-3 minutes, and add 1-2mg of midazolam if the patient is unable to tolerate coughing or movement during the examination. Reevaluate the MOAA/S score, and continue the operation after 2-3 minutes;

  • Intravenous general anesthesia group

    Procedure/Surgery

    Intravenous general anesthesia group (Group B): sufentanil 0.05-0.1 μ G/kg, administration time 30 seconds, 1mg/kg of propofol administered 2 minutes before examination. Depending on the patient's sleep status, 10mg of propofol can be administered every 30 seconds; Evaluate the patient's MOAA/S score. At 0-1 points, a digestive endoscope is inserted. If there is coughing or physical activity during the examination that the patient cannot tolerate, propofol 10-20mg can be administered multiple times. Evaluate the MOAA/S score again, and continue the operation after 0-1 points.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: The conscious sedation groupExperimental treatment 1 intervention
Group B: Intravenous general anesthesia groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse cardiovascular events

The occurrence rate of heart rate abnormal events (defined as heart rate abnormal events with a baseline fluctuation of ± 30%);The incidence of blood pressure fluctuation events (defined as blood pressure fluctuation events with a baseline blood pressure fluctuation of ± 30%);The incidence of angina, myocardial infarction, cardiac arrest, acute heart

Time frame
during the examination and recovery room time(up to 2 hours)

Secondary outcomes

1

The incidence of other adverse events

The incidence of other adverse events (SPO2\<90%, apnea, physical activity, pain, coughing, aspiration, muscle tremor, nausea and vomiting, difficulty breathing, etc.)

Time frame
during the examination and recovery room time(up to 2 hours)
2

VAS score

VAS score, also known as visual simulation score, can be divided into 10 equal parts, with 0 being no pain and 10 being the most painful.

Time frame
during the examination and recovery room time(up to 2 hours)
3

Satisfaction score

Satisfaction of patients, endoscopists, and anesthesiologists.The can be divided into 10 equal parts, with 0 being no satisfaction and 10 being the most satisfaction.

Time frame
during the examination and recovery room time(up to 2 hours)

Other outcomes

Sponsors and contacts

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