Hypokalemia and Intravenous Patient Controlled Analgesia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
General Anesthesia Laparoscopic Cholecystectomy |
Drug: IV-PCA Drug: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hypokalemia and Intravenous Patient Controlled Analgesia |
- plasma potassium concentration [ Time Frame: one day interval (average) ] [ Designated as safety issue: No ]
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)
- Visual Analogue Scale (VAS) score [ Time Frame: one day interval (average) ] [ Designated as safety issue: No ]
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)
| Enrollment: | 50 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Control-group
|
Drug: Control
control group (No-PCA group)
Other Name: no drug
|
|
Experimental: IV-PCA
IV-PCA group
|
Drug: IV-PCA
IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr
Other Name: fentanyl
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Won Ho Kim M.D., Seoul Medical Center |
| ClinicalTrials.gov Identifier: | NCT01269099 History of Changes |
| Other Study ID Numbers: | SMC-2010-01-24 |
| Study First Received: | December 30, 2010 |
| Last Updated: | January 3, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul Medical Center:
|
hypokalemia intravenous patient controlled analgesia |
Additional relevant MeSH terms:
|
Hypokalemia Potassium Deficiency Water-Electrolyte Imbalance Metabolic Diseases Deficiency Diseases Malnutrition Nutrition Disorders Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 23, 2013