Comparison of Hypertonic saline solution and Mannitol to improve brain relaxation during craniotomy in patients with brain tumor: A prospective randomized - controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20211027001

Enrollment

Registered

2021-10-27

Start date

2021-11-02

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients with brain tumor Hypertonic saline, Hypertonic saline solution, Hypertonic solution, HTS, Mannitol, brain relaxation, craniotomy, brain tumor

Interventions

3% NaCl solution 3 ml/kg IV,20%Mannitol solution 3 ml/kg IV

Active Comparator Drug,Active Comparator Drug

Hypertonic saline solution,Mannitol

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.ASA physical status classification I-III 2.GCS 13-15 3.Clinical manifestations or radio-imaging refers to increased intracranial pressure(IICP)

Exclusion criteria

Exclusion criteria: 1.Previous craniotomy, VP shunt or ventriculostomy 2.Receiving Hypertonic saline solution, Mannitol or diuretics in last 24 hours 3.Allergy or contraindications for Mannitol; HF, pulmonary congestion, CKD stage 3-5 4.Seizure or BT above 38 in last 24 hours 5.Serum Na level < 130 or > 150 mEq/dL 6.Self-determination

Design outcomes

Primary

Measure	Time frame
Brain relaxation immediately after dural opening Four-point brain relaxation score	—

Secondary

Measure	Time frame
Hemodynamic parameters during the operation MAP, PPV	—

Countries

Thailand

Contacts

Public ContactWorapoom Tangphikunatam

Khon Kaen University

worapoom.t@gmail.com043348390

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026