Hypokalemia and Intravenous Patient Controlled Analgesia

This study has been completed.
Sponsor:
Information provided by:
Seoul Medical Center
ClinicalTrials.gov Identifier:
NCT01269099
First received: December 30, 2010
Last updated: January 3, 2011
Last verified: December 2010

December 30, 2010
January 3, 2011
January 2010
December 2010   (final data collection date for primary outcome measure)
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)

Same as current
Complete list of historical versions of study NCT01269099 on ClinicalTrials.gov Archive Site
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)

Same as current
Not Provided
Not Provided
 
Hypokalemia and Intravenous Patient Controlled Analgesia
Hypokalemia and Intravenous Patient Controlled Analgesia

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • General Anesthesia
  • Laparoscopic Cholecystectomy
  • 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
  • Drug: Control
    control group (No-PCA group)
    Other Name: no drug
  • Active Comparator: Control
    Control-group
    Intervention: Drug: Control
  • Experimental: IV-PCA
    IV-PCA group
    Intervention: Drug: IV-PCA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01269099
SMC-2010-01-24
No
Won Ho Kim M.D., Seoul Medical Center
Seoul Medical Center
Not Provided
Principal Investigator: Won Ho Kim, M.D. Seoul Medical Center
Seoul Medical Center
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP