The Effect of Mannitol on the Serum Potassium During Craniotomy
Sponsor
The Affiliated Hospital of Xuzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03161977
Collaborator
(none)
30
1
5
6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Study Type:
Observational
Actual Enrollment
:
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Effect of Mannitol on Intraoperative Serum Potassium in Patients Undergoing Craniotomy：an Observational Study
Actual Study Start Date
:
Jan 1, 2017
Actual Primary Completion Date
:
Jun 1, 2017
Actual Study Completion Date
:
Jun 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Mannitol Mannitol was intravenous infused within 15-20 mins when drilling skull |
Other: Mannitol
Mannitol was intravenous infused within 15-20 mins when drilling skull
|
Outcome Measures
Primary Outcome Measures
- the concentration of serum potassium [two hours within infusioning mannitol]
measured by arterial blood gas analysis
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China | 221000 |
Sponsors and Collaborators
- The Affiliated Hospital of Xuzhou Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Better OS, Rubinstein I, Winaver JM, Knochel JP. Mannitol therapy revisited (1940-1997). Kidney Int. 1997 Oct;52(4):886-94. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61.
- 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.
- WINTERS RW, SCAGLIONE PR, NAHAS GG, VEROSKY M. THE MECHANISM OF ACIDOSIS PRODUCED BY HYPEROSMOTIC INFUSIONS. J Clin Invest. 1964 Apr;43:647-58.
Responsible Party:
The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier:
NCT03161977
Other Study ID Numbers:
- XYFY-2017-011
First Posted:
May 22, 2017
Last Update Posted:
Jul 31, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: