Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conditions
Brief summary
To investigate the effects of propofol vs. cyclopropofol and sufentanil vs. esketamine on intraoperative hypoxemia and hypotension in elderly patients undergoing ERCP, as well as the interaction between these two factors.
Interventions
DRUGAnesthesia induction using propofol+sufentanil
Anesthesia induction using propofol+sufentanil
DRUGAnesthesia induction using propofol+esketamine
Anesthesia induction using propofol+esketamine
DRUGAnesthesia induction using ciprofol+sufentanil
Anesthesia induction using ciprofol+sufentanil
DRUGAnesthesia induction using ciprofol+es-ketamine
Anesthesia induction using ciprofol+esketamine
Sponsors
Gang Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years old. * ASA II-III level. * BMI\<30kg/m2. * Patients who require elective therapeutic ERCP. * Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.
Exclusion criteria
* Previous anatomical changes in the gastrointestinal tract, delayed gastric emptying, and gastric outlet obstruction. * Coagulation dysfunction or tendency towards nosebleeds. * Combined severe heart disease (coronary heart disease, myocardial infarction, congestive heart failure, left ventricular ejection fraction\<40%, tachyarrhythmia) * Have a history of allergies to relevant anesthetic drugs in the past. * Severe pulmonary diseases (severe asthma attacks, respiratory failure, severe chronic obstructive pulmonary disease, severe interstitial lung disease, large pleural effusion, severe pulmonary arterial hypertension, etc.). * Existing upper respiratory tract infection (within one week). * Uncontrolled severe hypertension. * Patients with increased intracranial pressure; Cerebral hemorrhage, intracranial space occupying lesions, acute phase of traumatic brain injury. * Glaucoma and significant increase in intraocular pressure. * Untreated or inadequately treated patients with hyperthyroidism. * Serious liver and kidney diseases. * Known neurological and psychiatric disorders (Parkinson's disease, epilepsy, or schizophrenia). * Difficult airway: The anesthesiologist assessed the presence of difficult airway before surgery. * Vulnerable groups other than the elderly/illiterate, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hypoxemia | perioperative | SpO2≤92% |
| Hypotension | Perioperative | blood pressure drop exceeding 20% of the baseline value, with mean arterial pressure ≤65 mmHg or systolic blood pressure ≤90 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe hypoxemia | Perioperative | 75% ≤ SpO2\<90%\>60 s, SpO2\<75%. |
| Hypotension/hypertension requiring the use of vasopressors. | Perioperative | Hypotension/hypertension requiring the use of vasopressors. |
| Body movement. | Perioperative | During ERCP, the patient's body movement affected the surgical procedure |
| Coughing | Perioperative | During ERCP, the patient experienced coughing, which affected the surgical progress |
| Hiccup | Perioperative | During ERCP, the patient experienced Hiccup, which affected the surgical progress。 |
| Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation | Perioperative | Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation |
| Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute). | Perioperative | Tachycardia (HR\>100 beats/minute) or bradycardia (HR\<50 beats/minute). |
| The dosage of remifentanil used. | Perioperative | The dosage of remifentanil used. |
| Recovery room time | Perioperative | The time from removing the endoscope to reaching an Aldrete score of 10 in the endoscopic recovery room and leaving the room. |
| Postoperative recovery quality (QoR-15 scale score) | The first day after surgery. | Use the QOR15 rating scale for scoring, with higher scores indicating better recovery quality |
| Postoperative nausea and vomiting. | postoperative | the incidence of postoperative nausea and vomiting. |
| Patient satisfaction | postoperative day 1 | A 10 point visual analog scale was used to evaluate patient satisfaction with sedation types. Among them, 1 represents the worst experience, and 10 represents the best experience. The first day after ERCP, patients record their experience by checking the corresponding score on this scale. |
| Endoscope satisfaction | postoperative Day 1 | A 10 point visual analog scale was used to evaluate endoscope satisfaction with sedation types. Among them, 1 represents the worst experience, and 10 represents the best experience. |
| Hospitalization duration | after discharge | The total length of hospital stay for the patient in this treatment |
Contacts
CONTACTXiaocui Lv
Outcome results
None listed