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Effects of permissive hypercapnia on intraoperative cerebral oxygenation and early postoperative cognitive function in elderly patients with non-acute fragile brain function undergoing laparoscopic colorectal surgery

Effects of permissive hypercapnia on intraoperative cerebral oxygenation and early postoperative cognitive function in elderly patients with non-acute fragile brain function undergoing laparoscopic colorectal surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062093
Enrollment
Unknown
Registered
2022-07-21
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Colorectal cancer

Interventions

Permissive hypercapnia:Ventilation parameters: Tidal volume 6 ~ 8mL/kg, Respiratory rate 12 ~ 14 bpm, Suction/Respiration ratio 1:2, PaC02 45 ~ 55mmHg, pH >. 7.2,PEEP 0 cmH2O, FiO2 40%
Conventional ventilation:Ventilation parameters: Tidal volume10 ~ 12mL/kg, Respiratory rate 14 ~ 16 bpm, Suction/Respiration ratio 1:2, PaCO2 35 ~ 45mmHg,PEEP 0 cmH2O, FiO2 40%

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: ? ASA I-III; ? Age = 65 years old; ? BMI 18-28 kg/m2; ? Preoperative MMSE score =23; ? Conscious and able to think independently; ? Laparoscopic colorectal cancer surgery is planned, with no contraindications; ? Fragile brain function in non-acute stage (history of cerebral hemorrhage, cerebral infarction, TIA, craniocerebral vascular stenosis, PD, long-term headache and dizziness, no attack within three months and no corresponding clinical symptoms); ? Consent to participate in the trial

Exclusion criteria

Exclusion criteria: ? Patients with intracranial hypertension (hydrocephalus, brain tumor, brain space occupying lesions, etc.); ? The forehead has a history of surgery, trauma or skin lesions, infected; ? Patients with a history of severe depression, schizophrenia or other psychiatric disorders or who have taken antipsychotic or antidepressant drugs; ? Patients with severe audio-visual impairment and unable to communicate normally; ? Patients with severe underlying diseases (such as acute coronary syndrome, severe arrhythmia, heart failure, liver and kidney failure, etc.) except hypertension, diabetes, COPD and fragile brain function-related diseases defined in the inclusion criteria; ? Preoperative moderate to severe anemia patients (Hb < 90 g/L); ? Preoperative arterial oxygen partial pressure < 70 mmHg; ? Patients who underwent laparoscopic colorectal surgery again within 7 days; ? Patients undergoing emergency surgery or undergoing open operation due to unexpected circumstances; ? Patients who have participated in other clinical studies that may affect the outcome of this study.

Design outcomes

Primary

MeasureTime frame
Absolute change in rSO2 from baseline (T0) to surgical completion (T4) in groups H and N.;

Secondary

MeasureTime frame
Cerebral oxygen metabolism related indexes at T1, T2, T3 and T4 during surgery: rSO2, Da-jvO2 ml/L, CERO2 % (T1: 15 minutes after endotracheal intubation; T2: 60 min after pneumoperitoneum; T3: 120 min after pneumoperitoneum; T4: Suture completed, surgery completed);MMSE score and incidence of DNR 1 day before surgery and 1, 3 and 7 days after surgery;;Serum neuron-specific enolase (NSE) and interleukin-6 (IL-6) levels 1 day before and 1 day after surgery;;Incidence of intraoperative cerebral deoxygenation events (CDE): relative decrease of cerebral oxygen saturation from base value =20% or absolute value of rSO2 =55%;Anesthesia recovery time;Incidence of postoperative ICU admission events;30 days postoperative all-cause mortality;Incidence of postoperative pulmonary complications;The hospitalization duration;The incidence of postoperative adverse events (nausea, vomiting, hypotension, bradycardia, excessive sedation);

Countries

China

Contacts

Public ContactJun Chai
xiaopangzi76@163.com+86 18940259928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026