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The effect of 3% hypertonic saline pretreatment on the postoperative neurological function recovery of middle-aged and elderly patients with prostate cancer and bladder cancer

The effect of 3% hypertonic saline pretreatment on the postoperative neurological function recovery of middle-aged and elderly patients with prostate cancer and bladder cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090831
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-11-20
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Increased intracranial pressure

Interventions

Hypertonic saline group:When the head was lowered for 30 minutes during the surgical operation, 4ml/kg of 3% hypertonic saline solution was rapidly intravenously infused into the HS group within 30 mi
Saline group:When the head was lowered for 30 minutes during the surgical operation, the NS group was instilled with 4ml/kg 0.9% isotonic saline solution within the same period of time.

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Middle aged and elderly patients (45-80 years old) who choose to undergo robot assisted prostate cancer and bladder cancer surgery; ASA classification levels I-III; Heart function NYHA classification I-II, ejection fraction EF>=50%; BMI0.30; Can complete the Mini Mental State Examination (MMSE) score before surgery.

Exclusion criteria

Exclusion criteria: Patients who refused to be enrolled; Patients with contraindications for hypertonic saline infusion: hypernatremia (preoperative blood sodium concentration > 150mmol/l), severe renal insufficiency, severe cardiac insufficiency (NYHA grade III-IV for cardiac function, ejection fraction EF<50%), coagulation disorders, phlebitis, etc. Combined with severe cardiovascular and cerebrovascular system diseases; Chronic obstructive pulmonary disease Severe liver dysfunction; Severe electrolyte imbalance; Patients with difficult airways; Has previously taken sedatives, antidepressants or anti-anxiety drugs; Has a history of drug or alcohol dependence; Have severe visual and hearing impairments; There was a lack of good cognitive function before the operation (if the patient's educational level was junior high school or higher, the MMSE score was < 24;) If the patient's years of education are less than 6 years, the MMSE score is less than 20. If the patient is illiterate, the MMSE score is less than 17. Patients who have received neoadjuvant chemotherapy; Patients whose heads are in a low position for more than 4 hours during surgery

Design outcomes

Primary

MeasureTime frame
Changes in the diameter of the optic nerve sheath;

Secondary

MeasureTime frame
Riker sedation-agitation score during the recovery period;Incidence of delirium;MMSE Scale;Regional cerebral oxygen saturation;Changes of serological biomarkers :S-100ß; BDNF before and after the operation;The incidence of adverse reactions such as postoperative eye pain, blurred vision, dizziness and headache, nausea and vomiting, and bulbar conjunctival edema in patients;Monitor the changes of arterial blood gas in the two groups of patients after they entered the room and during the operation;

Countries

China

Contacts

Public ContactLiu Cunming

Jiangsu Provincial People's Hospital

1335587409@qq.com+86 139 5189 0866

Outcome results

None listed

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