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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,090
Beijing Hospital
Beijing, Beijing Municipality, China
Zhejiang Tumor Hospital
Zhejiang, Hangzhou, China
Dalian Municipal Friendship Hospital
Dalian, Liaoning, China
Renji Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Incidence of hypoxia and severe hypoxia
hypoxia( 75%≤SpO2≤89% for\<60s);severe hypoxia(SpO2\<75%,or SpO2\<90% for \>60s)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of hypoxia
hypoxia( 75%≤SpO2≤89% for\<60s)
Time frame: 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)
Time frame: 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% )
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Success rate of gastroenteroscopy endoscope
Time frame: 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.
Time frame: 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
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
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