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

Phase 4

• Conditions: Patients with brain tumor; Hypertonic saline, Hypertonic saline solution, Hypertonic solution, HTS, Mannitol, brain relaxation, craniotomy, brain tumor

• Registration Number: TCTR20211027001
• Lead Sponsor: Faculty of Medicine, Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-27
• Study Completion: 2022-08-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 66

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain relaxation immediately after dural opening Four-point brain relaxation score

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters during the operation MAP, PPV