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Completed

NCT Number: NCT01269099

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.

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Key information

Conditions

General Anesthesia Hypokalemia Laparoscopic Cholecystectomy Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Medical Center

Seoul, 135-740, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV-PCA

Drug

IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr

Other names: fentanyl

Control

Drug

control group (No-PCA group)

Other names: no drug

Primary outcomes

  1. plasma potassium concentration

    Time frame: one day interval (average)

    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)

Secondary outcomes

  1. Visual Analogue Scale (VAS) score

    Time frame: one day interval (average)

    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)

Sponsors and collaborators

Lead sponsor

Seoul Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 4, 2011
Registry last updated
Jan 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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