Effect of cyclopofol on cerebral oxygen saturation and postoperative delirium in elderly patients undergoing laparoscopic gastrointestinal tumor surgery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078860

Enrollment

Unknown

Registered

2023-12-20

Start date

2023-12-20

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

gastrointestinal tumor

Interventions

Cyclopofol Group:Cypofol for anesthesia induction: 0.2~0.4mg/kg, cypofol for anesthesia maintenance: 0.8~2.4mg/kg/h

Propofol group:Propofol for anesthesia induction: 1.5~2.5 mg/kg, and propofol for anesthesia maintenance: 4~12 mg/kg/h

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1, 65= age =85 years old, gender is not limited; 2. Preoperative MMSE score was greater than 26 points; 3. For patients who plan to undergo laparoscopic gastrointestinal tumor surgery under general anesthesia, the operation time is expected to be about 2h~4h; 4. ASA anesthesia grade I ~ III; 5. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with history of mental and neurological diseases and related drug use history; 2. Patients with severe organic diseases or organ dysfunction; 3. Patients with severe visual, auditory and speech disorders who cannot communicate completed the score; 4. Refusing to sign informed consent.

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium;	—

Secondary

Measure	Time frame
The general information of all patients was recorded, including age, sex, body mass index, and preoperative MMSE score;Local cerebral oxygen saturation before anesthesia induction (T0), after intubation (T1), at the beginning of surgery (T2), 10min after surgery (T3), 30min after surgery (T4), 1h (T5), at the end of surgery (T6), and at extubation (T7); Heart rate, respiratory rate, pulse oxygen saturation, systolic blood pressure, diastolic blood pressure, mean arterial pressure, arterial partial oxygen pressure (PaO2), arterial partial carbon dioxide pressure (PaCO2), etc;The time required for BIS value to recover from drug withdrawal to 90, the time from drug withdrawal to extubation, and the time from drug withdrawal to orientation recovery were recorded.;Records: operation duration, intraoperative blood loss and fluid rehydration volume; After anesthesia, nausea, vomiting, bradycardia, chills, hypotension and other adverse reactions;;RASS was used to assess patients for emergence agitation.;	—

Measure

Time frame

The general information of all patients was recorded, including age, sex, body mass index, and preoperative MMSE score;Local cerebral oxygen saturation before anesthesia induction (T0), after intubation (T1), at the beginning of surgery (T2), 10min after surgery (T3), 30min after surgery (T4), 1h (T5), at the end of surgery (T6), and at extubation (T7); Heart rate, respiratory rate, pulse oxygen saturation, systolic blood pressure, diastolic blood pressure, mean arterial pressure, arterial partial oxygen pressure (PaO2), arterial partial carbon dioxide pressure (PaCO2), etc;The time required for BIS value to recover from drug withdrawal to 90, the time from drug withdrawal to extubation, and the time from drug withdrawal to orientation recovery were recorded.;Records: operation duration, intraoperative blood loss and fluid rehydration volume; After anesthesia, nausea, vomiting, bradycardia, chills, hypotension and other adverse reactions;;RASS was used to assess patients for emergence agitation.;

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Countries

China

Contacts

Public ContactWeidong Liang

First Affiliated Hospital of Gannan Medical College

lwd0929@gmu.edu.cn+86 159 7012 2157

Outcome results

None listed

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