[Translation] A multicenter, randomized, double-blind, positive parallel controlled clinical study to evaluate the effectiveness and safety of mannitol sorbitol injection in treating cerebral edema caused by various reasons and reducing intracranial pressure, using mannitol injection as a control.

主要目的：以各种原因引起的脑水肿伴颅内压升高患者为对象，评价甘露醇山梨醇注射液与甘露醇注射液降低颅内压的有效性。次要目的：观察甘露醇山梨醇注射液的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of mannitol sorbitol injection and mannitol injection in reducing intracranial pressure in patients with cerebral edema caused by various reasons and increased intracranial pressure. Secondary objective: To observe the safety of mannitol sorbitol injection.

Start Date-

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242793 / Not yet recruitingNot Applicable

评价甘露醇山梨醇注射液对颅内压增高受试者的有效性及安全性的区组随机、双盲、阳性药平行对照临床试验

[Translation] A block randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of mannitol sorbitol injection in subjects with increased intracranial pressure

比较试验药与对照药用于颅内压增高患者的有效性及安全性，以验证试验药物降颅内压的疗效及安全性。

[Translation]

Compare the effectiveness and safety of the experimental drug and the control drug in patients with increased intracranial pressure to verify the efficacy and safety of the experimental drug in reducing intracranial pressure.

Start Date-

Sponsor / Collaborator

Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd.

100 Clinical Results associated with Mannitol/Sorbitol

100 Translational Medicine associated with Mannitol/Sorbitol

100 Patents (Medical) associated with Mannitol/Sorbitol

Literatures (Medical) associated with Mannitol/Sorbitol

01 Jan 1999·European UrologyQ1 · MEDICINE

Sorbitol-Mannitol Solution for Urological Electrosurgical Resection – A Safer Fluid than Glycine 1.5&percnt;

Q1 · MEDICINE

Article

Author: Dawkins, G P ; Miller, R A

OBJECTIVETo evaluate the safety and suitability of sorbitol-mannitol solution (Purisole((R)), Fresenius, Germany) as a fluid for irrigation during electrosurgical resection of prostate (TURP).PATIENTS AND METHODS120 sequential patients undergoing TURP were studied. Serum electrolytes were measured before and the day after surgery. Time and weight of resection were recorded. Use of blood transfusion was recorded.RESULTSThere were no adverse effects attributable to the use of the irrigant. There were no technical, electrical or instrument problems. None of the surgeons had any difficulties with clarity of view during resection when bleeding was light. There was no significant change in any of the serum electrolytes between pre-operative and postoperative values. No patient developed significant postoperative hyponatraemia or the 'TUR syndrome'.CONCLUSIONSPurisole (sorbitol-mannitol) solution is entirely satisfactory as an irrigant for electrosurgical resection and in the present study there were no measurable changes in patients' electrolytes around the time of surgery. What small changes occurred indicate there is an overall mild dehydration effect through the process of surgery, which may be in part attributable to irrigant, but this change was small and does not reach either clinical or statistical significance. Purisole offers theoretical advantages over glycine solution and there are no obvious disadvantages. The authors would thereby recommend it in preference to glycine.

100 Deals associated with Mannitol/Sorbitol

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Renal Insufficiency	JP	Yoshindo, Inc.	27 Dec 1966

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