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Completed

NCT Number: NCT05518929

Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age, ≤18 and ≤80 years, no gender limit
  • Undergoing routine gastrointestinal endoscopic diagnosis and treatment
  • American Society of Aneshesiologists (ASA) classification I-II
  • Body mass index (BMI) ≥ 23kg/m2
  • Estimated procedure duration less than 30 min
  • Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion criteria

  • Need to perform complicated endoscopic techniques for diagnosis and treatment, such as cholangiopancreatography surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa stripping, and oral endoscopic muscle dissection
  • Intend to undergo tracheal intubation or laryngeal mask
  • Patients' SpO2 ≤ 95% after entering the endoscope room;
  • Be definitely diagnosed as obstructive sleep apnea hypopnea syndrome;
  • Body weight < 40kg
  • Have serious heart diseases such as severe arrhythmia, heart failure, Adams-Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets
  • Systolic blood pressure ≥ 180mmhg or / and diastolic blood pressure ≥ 110mmhg measured in the endoscope room
  • Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months, acute respiratory tract infection within 1 week, and obvious symptoms such as fever, wheezing, nasal congestion and cough
  • There is an uncontrolled disease history with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which may not be suitable for participating in the study
  • Pregnant or breast-feeding women
  • Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
  • Participated in other clinical trials as a subject within 3 months
  • Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
  • Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
  • Patients who the investigator considers inappropriate to participate in this trial

Treatment and study plan

ciprofol

Drug

The sedation of gastrointestinal endoscopy with Ciprofol

Propofol

Drug

The sedation of gastrointestinal endoscopy with Propofol

Primary outcomes

  1. Incidence of hypoxia and severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    hypoxia( 75%≤SpO2≤89% for<60s);severe hypoxia(SpO2<75%,or SpO2<90% for >60s)

Secondary outcomes

  1. Incidence of hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    hypoxia( 75%≤SpO2≤89% for<60s)

  2. Incidence of severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    severe hypoxemia(SpO2<75%,or SpO2<90% for >60s)

  3. Incidence of subclinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    subclinical respiratory depression(90% ≤SpO2 ≤95% )

  4. Success rate of gastroenteroscopy endoscope

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  5. Incidence of injection pain when the intravenous administration of Ciprofol or propofol for sedation assessed by questionnaire.

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    Patients complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness.

  6. Proportion of corrective hypoxic measures

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    Treatment of patients with hypoxia

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Beijing Hospital
  • Dalian Municipal Friendship Hospital
  • Second Hospital of Shanxi Medical University
  • Zhejiang Tumor Hospital

Registry information

Official study title

The Incidences Of Hypoxia And Severe Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol Compared With Propofol In Overweight Or Obesity Adults Patients, A Multicenter, Randomized, Controlled Trial

Acronym: SpO2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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