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| Name | Class |
|---|---|
| Zhejiang Tumor Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Second Hospital of Shanxi Medical University | OTHER |
| Dalian Municipal Friendship Hospital |
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Ciprofol is a new general anesthetic, which combine with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in the sedation for gastrointestinal endoscopy, especially for overweight and obese patients. We conduct a Multicenter, Randomized, Open-label, Propofol-controlled Study to Evaluate the incidence of hypoxia and severe hypoxia during Gastroenterological Endoscope sedated with CiProfol in Overweight or Obesity patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group(Propofol group) | Active Comparator | Anesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg |
|
| Experimental group(ciprofol group) | Experimental | Anesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | The sedation of gastrointestinal endoscopy with Ciprofol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxia and severe hypoxia | hypoxia( 75%≤SpO2≤89% for<60s);severe hypoxia(SpO2<75%,or SpO2<90% for >60s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxia | hypoxia( 75%≤SpO2≤89% for<60s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Incidence of severe hypoxia | severe hypoxemia(SpO2<75%,or SpO2<90% for >60s) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diansan Su | Department of Anesthesiology Renji Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 10000 | China | ||
| Zhejiang Tumor Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41626789 | Derived | Zhou R, Dai W, Su Z, Lian Y, Wen P, Zhang L, Kong L, Hua Z, Sun Y, Zhao H, Wang Q, Yu W, Su D. Ciprofol Versus Propofol for the Prevention of Hypoxia During Gastrointestinal Endoscopy Procedures in Overweight Patients: A Multicenter, Randomized, Controlled Trial. Dig Endosc. 2026 Feb;38(2):e70102. doi: 10.1111/den.70102. |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D013274 | Stomach Neoplasms |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| UNKNOWN |
Multicenter, Randomized, Open-label, Propofol-controlled
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| Propofol | Drug | The sedation of gastrointestinal endoscopy with Propofol |
|
| Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Incidence of subclinical respiratory depression | subclinical respiratory depression(90% ≤SpO2 ≤95% ) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Success rate of gastroenteroscopy endoscope | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Incidence of injection pain when the intravenous administration of Ciprofol or propofol for sedation assessed by questionnaire. | Patients complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Proportion of corrective hypoxic measures | Treatment of patients with hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Zhejiang |
| Hangzhou |
| 310000 |
| China |
| Dalian Municipal Friendship Hospital | Dalian | Liaoning | China |
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030000 | China |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |