The Effect of Mannitol on the Serum Potassium During Craniotomy

Hyperkalemia Clinical Trial

Official title:

The Effect of Mannitol on Intraoperative Serum Potassium in Patients Undergoing Craniotomy：an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161977
• Other study ID #: XYFY-2017-011
• Status: Completed
• Phase: N/A
• First received: May 11, 2017
• Last updated: July 27, 2017
• Start date: January 1, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: January 2017
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy.

Description:

Patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously 15-20 minutes at the time of drilling skull.The serum potassium was measured by arterial blood gas analysis before infusion (T0), infusion finished (T1), 15min (T2), 30min (T3), 60min (T4) and 120min (T5) after infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 18 to 70

• American Society of Anesthesiologists physical status I to II

• liver and kidney function is normal

• preoperative concentration of serum potassium was from 3.5 to 5.5 mmol/L

Exclusion Criteria:

• history or presence of congestive heart failure (New York Heart Association class III to IV)

• history or presence of renal failure(diabetes insipidus, or syndrome of inappropriate antidiuretic hormone secretion)

• intraoperative blood transfusion

Related Conditions & MeSH terms

• Hyperkalemia
• Mannitol Adverse Reaction

Intervention

Other:
• Mannitol
Mannitol was intravenous infused within 15-20 mins when drilling skull

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (12)

Better OS, Rubinstein I, Winaver JM, Knochel JP. Mannitol therapy revisited (1940-1997). Kidney Int. 1997 Oct;52(4):886-94. Review. — View Citation

Fanous AA, Tick RC, Gu EY, Fenstermaker RA. Life-Threatening Mannitol-Induced Hyperkalemia in Neurosurgical Patients. World Neurosurg. 2016 Jul;91:672.e5-9. doi: 10.1016/j.wneu.2016.04.021. Epub 2016 Apr 13. — View Citation

Hirota K, Hara T, Hosoi S, Sasaki Y, Hara Y, Adachi T. Two cases of hyperkalemia after administration of hypertonic mannitol during craniotomy. J Anesth. 2005;19(1):75-7. — View Citation

Maas AI, Dearden M, Teasdale GM, Braakman R, Cohadon F, Iannotti F, Karimi A, Lapierre F, Murray G, Ohman J, Persson L, Servadei F, Stocchetti N, Unterberg A. EBIC-guidelines for management of severe head injury in adults. European Brain Injury Consortium. Acta Neurochir (Wien). 1997;139(4):286-94. — View Citation

Manninen PH, Lam AM, Gelb AW, Brown SC. The effect of high-dose mannitol on serum and urine electrolytes and osmolality in neurosurgical patients. Can J Anaesth. 1987 Sep;34(5):442-6. Review. — View Citation

Palma L, Bruni G, Fiaschi AI, Mariottini A. Passage of mannitol into the brain around gliomas: a potential cause of rebound phenomenon. A study on 21 patients. J Neurosurg Sci. 2006 Sep;50(3):63-6. — View Citation

Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25. — View Citation

Rozet I, Tontisirin N, Muangman S, Vavilala MS, Souter MJ, Lee LA, Kincaid MS, Britz GW, Lam AM. Effect of equiosmolar solutions of mannitol versus hypertonic saline on intraoperative brain relaxation and electrolyte balance. Anesthesiology. 2007 Nov;107(5):697-704. — View Citation

Seto A, Murakami M, Fukuyama H, Niijima K, Aoyama K, Takenaka I, Kadoya T. Ventricular tachycardia caused by hyperkalemia after administration of hypertonic mannitol. Anesthesiology. 2000 Nov;93(5):1359-61. — View Citation

Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. — View Citation

The Brain Trauma Foundation. The American Association of Neurological Surgeons. The Joint Section on Neurotrauma and Critical Care. Initial management. J Neurotrauma. 2000 Jun-Jul;17(6-7):463-9. — View Citation

WINTERS RW, SCAGLIONE PR, NAHAS GG, VEROSKY M. THE MECHANISM OF ACIDOSIS PRODUCED BY HYPEROSMOTIC INFUSIONS. J Clin Invest. 1964 Apr;43:647-58. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the concentration of serum potassium	measured by arterial blood gas analysis	two hours within infusioning mannitol