Effect of Ciprofol Injection on Postoperative Cognitive Function
25. juni 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
298
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400010
- The Second Affiliated Hospital of Chongqing Medical University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intraoperative and postoperative adverse events
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
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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)
Tidsramme: 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)
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The dosage of propofol/ciprofol used
Tidsramme: 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)
|
|
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The patient's stay time in the PACU（Post-Anesthesia Care Unit）
Tidsramme: up to 24 hours
|
The period from when the patients enter the PACU until they leave the PACU
|
up to 24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2026
Primær færdiggørelse (Anslået)
30. december 2026
Studieafslutning (Anslået)
30. december 2026
Datoer for studieregistrering
Først indsendt
9. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-166
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