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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01269099
Other study ID # SMC-2010-01-24
Secondary ID
Status Completed
Phase N/A
First received December 30, 2010
Last updated January 3, 2011
Start date January 2010
Est. completion date December 2010

Study information

Verified date December 2010
Source Seoul Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
IV-PCA
IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr
Control
control group (No-PCA group)

Locations

Country Name City State
Korea, Republic of Seoul Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
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