Comparison of Acid-Base and Electrolytes Imbalance in Normal Saline and Bicarbonate 1⁄6 Molar Intravenous Fluid Infusions during Cervical and Lumbar Laminectomy: A Pilot Double-Blinded Clinical Trial
This study aimed to compare electrolytes and acid-base imbalance occurrence in two fluid therapy methods using normal saline and 1/6 molar sodium bicarbonate in cervical and lumbar laminectomy surgeries.
35 to 70 years old patients with ASA class I and II, candidate for cervical and lumbar spinal laminectomy referred to Baqiyatallah Hospital in 2014 were enrolled. Patients with chronic kidney disease, hepatic failure, electrolytes imbalance, changes in blood pressure more than 30% of basal amount, needing blood transfusion before and during operation were excluded from study. Patients were randomized into two groups by a computer generalized list (20 patients in each group). Fluids needed were calculated in all patients. Maintenance fluid therapy was done using normal saline and deficit fluid therapy was done using 1⁄6 molar sodium bicarbonate in first group, while maintenance and deficit fluid therapies were done using normal saline in the second group. All other anesthesia processes were the same in the both group. Sodium bicarbonate 1⁄6 molar was produced using 150 mL sodium bicarbonate 7.5% added to 850 mL infusible distilled water identical in shape and size with normal saline fluid by another anesthesiologist. Drug prescriber, who filled the checklists in all stages as well as the person who performed the analysis were unaware of infused fluid in both groups. All patients were evaluated using arterial blood gasses, blood electrolytes levels, and hemodynamic factors before and after the operation. Collected data were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061717413N4
Registration date:2015-03-28, 1394/01/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-28, 1394/01/08
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
Expected recruitment start date
2014-07-11, 1393/04/20
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Acid-Base and Electrolytes Imbalance in Normal Saline and Bicarbonate 1⁄6 Molar Intravenous Fluid Infusions during Cervical and Lumbar Laminectomy: A Pilot Double-Blinded Clinical Trial
Public title
Acid-Base and Electrolytes Imbalance in Normal Saline and 1/6 Molar Sodium Bicarbonate Infusions during Surgical Laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 35 to 70 years old patients; with ASA class I and II; candidate for cervical and lumbar spinal laminectomy.
Exclusion criteria: Patients with chronic kidney disease; hepatic failure; electrolytes imbalance; changes in blood pressure more than 30% of basal amount; needing blood transfusion before and during operation.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei Street, Mollasadra Street, Vanak Square, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2014-02-07, 1392/11/18
Ethics committee reference number
36-4
Health conditions studied
1
Description of health condition studied
Nerve root and plexus compressions in intervertebral disc disorders
ICD-10 code
G55.1
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders
2
Description of health condition studied
electrolyte and acid-base imbalance
ICD-10 code
E87
ICD-10 code description
Other disorders of fluid, electrolyte and acid-base balance
Primary outcomes
1
Description
Electrolytes imbalance
Timepoint
After the surgery
Method of measurement
Electrolytes level checking in patients' blood sample
2
Description
Acid-base imbalance
Timepoint
After the surgery
Method of measurement
Arterial blood gasses levels in patients' arterial blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Maintenance fluid therapy was done using normal saline and deficit fluid therapy was done using 1⁄6 molar sodium bicarbonate in the first group.
Category
Treatment - Drugs
2
Description
All maintenance and deficit fluid therapies were done using normal saline in the second group.