Hypokalemia and Intravenous Patient Controlled Analgesia

Study Overview
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Brief Summary
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The increase in stress hormone level and hyperventilation caused by the postoperative pain may contribute to the development of hypokalemia during postoperative period. Therefore, if the postoperative pain is well controlled by the IV-PCA,the plasma potassium level during the postoperative period may be not affected by stress response. The researchers tried to investigate the effect of IV-PCA on potassium regulation during the postoperative period.

Detailed Description
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Intravenous patient controlled analgesia(IV-PCA) has been widely used to control postoperative pain. The increase in stress hormone level and hyperventilation caused by the postoperative pain may contribute to the development of hypokalemia during postoperative period. Hypokalemia is a risk factor for postoperative arrhythmia. Therefore, if the postoperative pain is well controlled by the IV-PCA, the plasma potassium level during the postoperative period may be not affected by stress response, and the incidence of hypokalemia may be reduced. The researchers tried to investigate the effect of IV-PCA on potassium regulation during the postoperative period. The researchers divided the patients undergoing laparoscopic cholecystectomy into two groups of IV-PCA group and control group. The researchers compared the plasma potassium concentration from the preoperative to postoperative period.

Official Title
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Hypokalemia and Intravenous Patient Controlled Analgesia

Conditions
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General Anesthesia, Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: IV-PCA
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic cholecystectomy ASA class I or II Exclusion Criteria: Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome Patients with recent exogenous steroid administration or previous diuretics therapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control-group | Drug: Control<br>* control group (No-PCA group)<br>* Other names: no drug;|
| Experimental: IV-PCA<br>IV-PCA group | Drug: IV-PCA<br>* IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr<br>* Other names: fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma potassium concentration | blood sample for electrolyte including plasma potassium concentration checking six times ; at outpatient department (T1), at 08:00 A.M. of the day of surgery (T2), one hour after the end of surgery (T3), at 8:00 A.M. of first (T4), second (T5), and third postoperative day (T6) | one day interval (average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) score | patient-reported VAS score during postoperative period checking fourtimes ; one hour after the end of surgery (T3), at 8:00 A.M. of first (T4), second (T5), and third postoperative day (T6) | one day interval (average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypokalemia, intravenous patient controlled analgesia