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To explore the effect of subanesthetic-dose esketamine combined with different general anesthetic drugs on the quality of postoperative recovery in patients undergoing painless gastrointestinal endoscopy.
In this study, we planned to conduct a single-center, prospective, randomized, controlled, double-blind clinical trial to explore the effect of subanesthetic dose esketamine combined with different general anesthesia drugs on the postoperative recovery quality of patients undergoing painless gastrointestinal endoscopy combined with several commonly used intravenous general anesthesia drugs, aiming at gastroscopy combined with colonoscopy, a representative type of diagnosis and treatment of painless and comfortable anesthesia, and to provide more evidence-based medical evidence for clinical work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group C | Placebo Comparator | normal saline (0.15 ml/kg) + ciprofol (0.5 mg/kg) |
|
| group E | Experimental | esketamine (0.15 mg/kg) + ciprofol (0.5 mg/kg) |
|
| group P | Experimental | esketamine (0.15 mg/kg) + propofol (2 mg/kg) |
|
| group EC | Experimental | esketamine (0.15 mg/kg) + etomidate-ciprofol (EC) mixture (0.2 ml/kg) |
|
| group EP | Experimental | esketamine (0.15 mg/kg) + etomidate-propofol (EC) mixture (0.2 ml/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Drug | normal saline (0.15 ml/kg) |
| |
| esketamine |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-15 | The QoR-15 (Quality of Recovery-15) evaluates the quality of recovery across five dimensions: physical comfort (50 points), emotional state (40 points), physical independence (20 points), psychological support (20 points), and pain (20 points). The total score of the QoR-15 ranges from 0 (indicating the poorest quality of recovery) to 150 (representing the best quality of recovery). | Postoperative day 1 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative vital signs | The following parameters: Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Heart Rate (HR), and Peripheral Oxygen Saturation (SpO₂) were measured and recorded at the following time points: before anesthesia induction (T0), immediately after anesthesia induction (T1), at the moment when the gastroscope entered the larynx (T2), when the gastroscope was withdrawn from the pharyngeal cavity (T3), when the colonoscope entered the anus (T4), and at the completion of colonoscopy (T5). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 22500 | China |
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| Drug |
esketamine (0.15 mg/kg) |
|
|
| propofol | Drug | propofol (2 mg/kg) |
|
| etomidate-ciprofol (EC) mixture | Drug | etomidate-ciprofol (EC) mixture (0.2 ml/kg) |
|
| ciprofol | Drug | ciprofol (0.5 mg/kg) |
|
| etomidate-propofol (EP) mixture | Drug | etomidate-propofol (EP) mixture (0.2 ml/kg) |
|
| Perioperative |
| Anesthesia Recovery Time | The time interval between the last administration of general anesthetic agent(s) and the moment when the patient achieves a Modified Aldrete Score of ≥9. | during surgery and arrived at PACU (up to 30 minutes after surgery) |
| Procedure Duration | From the beginning of gastroscopy to the end of colonoscopy withdrawal | during surgery and arrived at PACU (up to 30 minutes after surgery) |
| PACU residence time | The time from entering the PACU to leaving the PACU after the end of gastroscopy combined with colonoscopy; | during surgery and arrived at PACU (up to 30 minutes after surgery) |
| Anesthetic drug use | Total amount of sedative medication used, number of cases of norepinephrine, and number of cases of remifentanil. | during surgery and arrived at PACU (up to 30 minutes after surgery) |
| The way the patient leaves the endoscopy center | The way in which the patient is discharged from the PACU after the anesthesia resuscitation is up to standard; | Postoperative |
| The length of the patient's stay in the hospital after leaving the endoscopy center in the PACU | The length of the patient's stay in the hospital from the time the patient leaves the PACU until he leaves the hospital. | Postoperative |
| The way the patient leaves the hospital | The patient's method of leaving the hospital, such as walking on their own, driving any means of transportation, etc. | Postoperative |
| Satisfaction score | Patient, anesthesiologist, and digestive endoscopist satisfaction with the whole gastroscopy combined with colonoscopy. Using the NRS, eleven numbers from 0-10 represent satisfaction, with 0 being dissatisfied and 10 being the most satisfied. | Postoperative |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| C000629870 | Esketamine |
| D015742 | Propofol |
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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