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To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol group (C group) | Active Comparator | Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg. |
|
| The group of remifentanil 0.5ug/kg combined with ciprofol(R group) | Experimental | R group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg. |
|
| The group of esketamine 0.3mg/kg combined with ciprofol(E1 group) | Experimental | E1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg. |
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| The group of esketamine 0.5mg/kg combined with ciprofol(E2 group) | Experimental | E2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil and ciprofol | Drug | R group will be started with remifentanil 0.5ug/kg and ciprofol 0.4 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score | Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result) | Baseline (30 min before surgery), postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score | Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 3(minimum value : 0, maximum value : 150, the higher the score, the better the result) | Postoperative day 3 and 7 |
| Cognitive function assessment |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of all drug-related adverse events | All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am). | Within 72hours after surgery |
Inclusion Criteria:
1. Scheduled painless gastroscopy examination and treatment
2. Age 60-75 years old
3. ASA grade ā -ā ”
4. The respiratory tract is unobstructed and there is no difficult airway
5. No history of allergy to etomidate and cyclopropofol
6. Participants with normal heart, liver, lung, and kidney functions
7. Able to complete the QoR-15, MMSE, and HADS scale assessments
8. lnformed consent, voluntary participation in the trial, and signed by the patient informed consent
Exclusion Criteria:
1. Participants with concurrent dysfunction of major organs.
2. Participants with a history of mental illness and abuse of sedative drugs
3. Participants with allergies or contraindications to the study drugs
4. Participants with severe visual, auditory, or speech communication impairments
5. Participants with acute gastrointestinal inflammation or obstruction
6. History of uncontrolled diabetes, hypertension, and hypotension
7. Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI > 30kg/m2)
8. Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.
9. Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Subei People's Hospital of Jiangsu Province | Yangzhou | Jiangsu | 225001 | China |
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| esketamine 0.3mg/kg and ciprofol | Drug | Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg. |
|
| esketamine 0.5mg/kg and ciprofol | Drug | Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg. |
|
| Ciprofol | Drug | Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg. |
|
A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE has a maximum total score of 30, with higher scores manifesting a better cognitive performance. |
| Baseline (30 min before surgery), postoperative day 1,3 and 7 |
| Hospital anxiety and depression scale ( HADS ) score. | Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1,3 and 7 , a score of 8 points or higher will be diagnosed as depression or anxiety. | Baseline (30 min before surgery), postoperative day 1,3 and 7 |
| Dosage of ciprofol | Consumption of ciprofol during endoscopic examination | During endoscopic examination |
| Heart rate (HR) | Throughout the procedure, the heart rate (HR) was continuously monitored. | Baselineļ¼during surgery and arrived at PACU (up to 30 minutes after surgery) |
| Pulse oxygen saturation (SpO2) | Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored. | Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery) |
| Mean blood pressure (MBP) | Throughout the procedure, the mean blood pressure (MBP) was measured at 1-minute intervals. | Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery) |
| Patient satisfaction levels | The patients express their satisfaction with procedures on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level. | 30 minutes at recovery room. |
| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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