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Effects of cyclopofol and propofol on the incidence of intraoperative hypotension, postoperative memory, sleep quality, and anti-anxiety in patients with painless gastroenteroscopy : Multicentre, prospective, double-blind, randomized controlled study

Effects of cyclopofol and propofol on the incidence of intraoperative hypotension, postoperative memory, sleep quality, and anti-anxiety in patients with painless gastroenteroscopy : Multicentre, prospective, double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092198
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence of intraoperative hypotension and postoperative memory, sleep quality and anti-anxiety

Interventions

Cyclopofol Group:Cyclopofol (0.4-0.6)mg/kg was injected intravenously for about 30 seconds. If there is a kinetic reaction during the examination, add cyclopofol (0.15-0.2)mg/kg.
Propofol Group:Propofol (1-3 mg/kg) was administered intravenously for about 30 seconds. If kinetic reactions occur during the examination, propofol (0.5-1)mg/kg should be added.

Sponsors

Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old < age <80 years old; ASA Class I - III (2) Male and female gender is not limited; (3) Choose to perform painless gastroenteroscopy and treat hospitalized patients (4) Before the trial, patients should have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, understand the research procedure and sign the informed consent in person.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women and those who have a birth plan within 3 months; (2) Patients with obvious respiratory and circulatory dysfunction and abnormal liver and kidney function before operation; (3) Patients with severe neuropsychiatric diseases; (4) Those who are allergic or contraindicated to drugs and their components such as cyclopofol or propofol; (5) long-term (more than 3 months) taking antidepressants, anti-anxiety drugs or other psychotropic drugs; (6) Inability to understand or refusal to complete the questionnaire; (7) Patients who are unable to obtain informed consent, or who are considered inappropriate by the investigator to participate in this trial.

Design outcomes

Primary

MeasureTime frame
The occurrence of intraoperative hypotension (systolic blood pressure less than 90mmHg or blood pressure reduction greater than 30% of the base blood pressure).;

Secondary

MeasureTime frame
The adverse reactions during anesthesia;Time of recovery from anesthesia;Adverse reactions during recovery;Sleep quality 1 day after surgery;Memory level 1 day after surgery;Occurrence of anxiety 1 day after surgery;Patient and endoscopist satisfaction scores;

Countries

China

Contacts

Public ContactWang Bin

Qingdao Municipal Hospital

wangbin328@sina.com+86 132 9542 6246

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026