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
  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

Resource links provided by NLM:


Further study details as provided by Seoul Medical Center:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269099

Locations
Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of, 135-740
Sponsors and Collaborators
Seoul Medical Center
Investigators
Principal Investigator: Won Ho Kim, M.D. Seoul Medical Center
  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 July 29, 2014