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Open Access Study protocol

The effect of mannitol on intraoperative brain relaxation in patients undergoing supratentorial tumor surgery: study protocol for a randomized controlled trial

Yuming Peng, Xiaoyuan Liu, Aidong Wang and Ruquan Han*

Author Affiliations

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 6, Tiantan Xili, Dongcheng District, Beijing, 100050, PR China

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Trials 2014, 15:165  doi:10.1186/1745-6215-15-165

Published: 10 May 2014

Abstract

Background

The risk of brain swelling after dural opening is high in patients with midline shift undergoing supratentorial tumor surgery. Brain swelling may result in increased intracranial pressure, impeded tumor exposure, and adverse outcomes. Mannitol is recommended as a first-line dehydration treatment to reduce brain edema and enable brain relaxation during neurosurgery. Research has indicated that mannitol enhanced brain relaxation in patients undergoing supratentorial tumor surgery; however, these results need further confirmation, and the optimal mannitol dose has not yet been established. We propose to examine whether different doses of 20% mannitol improve brain relaxation in a dose-dependent manner when administered at the time of incision. We will examine patients with preexisting mass effects and midline shift undergoing elective supratentorial brain tumor surgery.

Methods

This is a single-center, randomized controlled, parallel group trial that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Randomization will be achieved using a computer-generated table. The study will include 220 patients undergoing supratentorial tumor surgery whose preoperative computed tomography/magnetic resonance imaging results indicate a brain midline shift. Patients in group A, group B, and group C will receive dehydration treatment at incision with 20% mannitol solutions of 0.7, 1.0, and 1.4 g/kg, respectively, at a rate of 600 mL/h. The patients in the control group will not receive mannitol. The primary outcome is an improvement in intraoperative brain relaxation and dura tension after dehydration with mannitol. Secondary outcomes are postoperative outcomes and the incidence of mannitol side effects.

Discussion

The aim of this study is to determine the optimal dose of 20% mannitol for intraoperative infusion. We will examine brain relaxation and outcome in patients undergoing supratentorial tumor surgery. If our results are positive, the study will indicate the optimal dose of mannitol to improve brain relaxation and avoid side effects during brain tumor surgery.

Trial registration

The study is registered with the registry website http://www.chictr.org webcite with the registration number ChiCTRTRC13003984 (17 December 2013).

Keywords:
Randomized controlled trial; Mannitol; Brain relaxation; Supratentorial tumor