Effect of Ciprofol Injection on Postoperative Cognitive Function
25 juni 2026 uppdaterad av: Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University
A Controlled Study on the Impact of Ciprofol Injection on Postoperative Cognitive Function and Its Mechanism
This study aims to explore the effect of ciprofol on the postoperative cognitive function of inpatients undergoing gastrointestinal endoscopy examination, to compare the anesthetic effects and differences in adverse reactions of propofol and ciprofol in gastrointestinal endoscopy , to compare the incidence of postoperative cognitive decline in patients undergoing gastrointestinal endoscopy examination between propofol and coprofol, and to optimize the anesthesia medication regimen for patients undergoing gastrointestinal endoscopy examination.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
298
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400010
- The Second Affiliated Hospital of Chongqing Medical University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Age: 18-65 years old, ASA grade I-Ⅲ, BMI index: 18.5-30 kg/m ²
- Patients who plan to undergo gastroscopy or colonoscopy in our hospital
- The preoperative assessment of the MOCA scale in patients scheduled for elective surgery indicated normal cognitive function
- dextromanuality
- Voluntarily participate in this study and sign the informed consent form
Exclusion Criteria:
- Pregnant or lactating women
- Patients who have had cardiovascular and cerebrovascular accidents in the past
- Patients with severe diseases of the cardiovascular system, respiratory system and liver and kidney system
- Patients with obstructive sleep apnea syndrome
- Patients with concurrent neurological or mental system diseases, or those with incomplete intellectual development
- Patients allergic to ciprofol or propofol drugs
- Patients with braking, visual/auditory impairments
- Patients with psychotropic drug addiction or alcohol dependence
- Patients who themselves or their attending physicians refused to participate in the study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental group (ciprofol)
patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.
|
patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.
|
|
Aktiv komparator: Control group (propofol)
patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.
|
patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
Tidsram: From the time the patient was enrolled in the study to 24 hours after the treatment
|
From the time the patient was enrolled in the study to 24 hours after the treatment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraoperative and postoperative adverse events
Tidsram: From the time the patient enters the operating room to 24 hours after the treatment
|
From the time the patient enters the operating room to 24 hours after the treatment
|
|
|
Blood Pressure (mmHg)
Tidsram: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
Non-invasive BP measured by cuff after entry and intermittently during surgery.
Hypotension: SBP decrease >30% from baseline; Hypertension: SBP increase >30% from baseline.
|
From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
|
Heart Rate (beats/min)
Tidsram: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
Read from monitor.
Bradycardia: <50 bpm or decrease ≥25% from baseline; Tachycardia: >100 bpm or increase ≥25% from baseline.
|
From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
|
Respiratory Rate (breaths/min)
Tidsram: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
Read from monitor or counted over 1 min.
Respiratory depression: <8 breaths/min lasting >30 sec.
|
From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
|
Oxygen Saturation (Pulse Oximetry)
Tidsram: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
Read from monitor.
Hypoxemia: SpO2 <90% lasting >15 sec.
|
From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The dosage of propofol/ciprofol used
Tidsram: The dosage of drugs used during this period from anesthesia induction to the end of anesthesia (perioperative period) (approximately 25 - 60 minutes)
|
The dosage of drugs used during this period from anesthesia induction to the end of anesthesia (perioperative period) (approximately 25 - 60 minutes)
|
|
|
The patient's stay time in the PACU（Post-Anesthesia Care Unit）
Tidsram: up to 24 hours
|
The period from when the patients enter the PACU until they leave the PACU
|
up to 24 hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Beräknad)
30 december 2026
Avslutad studie (Beräknad)
30 december 2026
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
29 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-166
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