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a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.
Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol | Experimental | Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h)) |
|
| Propofol | Other | Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extubation time | Time interval between drug withdrawal and removal of the tracheal catheter | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Aldrete Score | In the PACU, Investigators using Aldrete score scale(0- 10 points) | up to 2 hours |
| Emergence Agitation | In the PACU, Investigators assessed emergence delirium using PAED 0-20 points) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mujun Chang, Dr. | Tongji Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| 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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| Propofol | Drug | Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h)) |
|
| up to 2 hours |
| Postoperative Pain | use the FLACC pain score(0- 10 points) | 24 hours |
| Postoperative nausea and vomiting | Investigators assessed postoperative nausea and vomiting BARF scale(0-10points) | 24 hours |
| satisfaction degree | Child and/or Parent Satisfaction Survey (0-10 points) | 24 hours |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |