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The impact of intraoperative isotonic versus hypotonic solutions on electrolytes in the recovery phase in children undergoing major neurosurgery: a randomized and double-blinded clinical trial

The impact of intraoperative isotonic versus hypotonic solutions on electrolytes in the recovery phase in children undergoing major neurosurgery: a randomized and double-blinded clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046539
Enrollment
Unknown
Registered
2021-05-21
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Hyponatremia

Interventions

Experimental group:Isotonic solution (acetic acid electrolyte balance solution)
Control group:Hypotonic solution (pediatric Electrolyte supplements injection)

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: Children aged 0 to 6 years undergoing elective intracranial epileptic foci excision under general anesthesia.

Exclusion criteria

Exclusion criteria: 1.Hyponatremia (serum natrium 155 mmol/L) preoperatively; 2.Operation duration < 30min; 3.Significant cardiovascular diseases; 4.Significant respiratory diseases; 5.Severe intracranial hypertension; 6.Refusal to participation by patients' guardians; 7.Already participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Poor serum sodium concentration;

Secondary

MeasureTime frame
Change of sodium ion level ;Incidence of hyponatremia and hyperchloremia;Changes of potassium ion, chloride ion, pH and alkali residue at each postoperative observation point compared with that before surgery;Brain relaxation score;

Countries

China

Contacts

Public ContactSong Linlin

Peking University First Hospital

songlinlinlynkia@163.com+86 10 83575138

Outcome results

None listed

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