Hypokalemia and Intravenous Patient Controlled Analgesia

NCT01269099 | Completed

• 1 other identifier: SMC-2010-01-24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia; Laparoscopic Cholecystectomy

Keywords

hypokalemia; intravenous patient controlled analgesia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Visual Analogue Scale (VAS) score

  one day interval (average)

Study Arms (2)

Control

ACTIVE COMPARATOR

Control-group

Drug: Control

IV-PCA

EXPERIMENTAL

IV-PCA group

Drug: IV-PCA

Interventions

IV-PCA DRUG

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

Also known as: fentanyl

IV-PCA

Control DRUG

control group (No-PCA group)

Also known as: no drug

Control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic cholecystectomy
• ASA class I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul Medical Center: lead

Study Sites (1)

Seoul Medical Center

Seoul, 135-740, South Korea

Location

MeSH Terms

Conditions

Hypokalemia

Interventions

Analgesia, Patient-Controlled; Fentanyl

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Won Ho Kim, M.D.

  Seoul Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 4, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2010-12

Locations

KR (1)