The Effect of Mannitol on the Serum Potassium During Craniotomy

NCT03161977 | Completed DMC

• 1 other identifier: XYFY-2017-011
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mannitol Adverse Reaction; Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• the concentration of serum potassium

  measured by arterial blood gas analysis

  two hours within infusioning mannitol

Study Arms (1)

Mannitol

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

Other: Mannitol

Interventions

Mannitol OTHER

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

Mannitol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who are received craniotomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Related Publications (12)

• 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.

  PMID: 23354336 BACKGROUND

• 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. doi: 10.1007/BF01808823.

  PMID: 9202767 BACKGROUND

• 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. doi: 10.1089/neu.2000.17.463.

  PMID: 10937888 BACKGROUND

• 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.

  PMID: 27086258 BACKGROUND

• Better OS, Rubinstein I, Winaver JM, Knochel JP. Mannitol therapy revisited (1940-1997). Kidney Int. 1997 Oct;52(4):886-94. doi: 10.1038/ki.1997.409. No abstract available.

  PMID: 9328926 BACKGROUND

• 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.

  PMID: 17019386 BACKGROUND

• 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. doi: 10.1097/01.anes.0000286980.92759.94.

  PMID: 18073543 BACKGROUND

• 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. doi: 10.1097/00000542-200011000-00036. No abstract available.

  PMID: 11046231 BACKGROUND

• WINTERS RW, SCAGLIONE PR, NAHAS GG, VEROSKY M. THE MECHANISM OF ACIDOSIS PRODUCED BY HYPEROSMOTIC INFUSIONS. J Clin Invest. 1964 Apr;43(4):647-58. doi: 10.1172/JCI104950. No abstract available.

  PMID: 14149918 BACKGROUND

• Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.

  PMID: 6423247 BACKGROUND

• 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. doi: 10.1007/BF03014345.

  PMID: 3117392 BACKGROUND

• 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. doi: 10.1007/s00540-004-0270-4.

  PMID: 15674521 BACKGROUND

MeSH Terms

Conditions

Hyperkalemia

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 22, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)