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Hypokalemia and Intravenous Patient Controlled Analgesia

Primary Purpose

General Anesthesia, Laparoscopic Cholecystectomy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IV-PCA
Control
Sponsored by
Seoul Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for General Anesthesia focused on measuring hypokalemia, intravenous patient controlled analgesia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

IV-PCA

Arm Description

Control-group

IV-PCA group

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
December 30, 2010
Last Updated
January 3, 2011
Sponsor
Seoul Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01269099
Brief Title
Hypokalemia and Intravenous Patient Controlled Analgesia
Official Title
Hypokalemia and Intravenous Patient Controlled Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia, Laparoscopic Cholecystectomy
Keywords
hypokalemia, intravenous patient controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control-group
Arm Title
IV-PCA
Arm Type
Experimental
Arm Description
IV-PCA group
Intervention Type
Drug
Intervention Name(s)
IV-PCA
Other Intervention Name(s)
fentanyl
Intervention Description
IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
no drug
Intervention Description
control group (No-PCA group)
Primary Outcome Measure Information:
Title
plasma potassium concentration
Description
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)
Time Frame
one day interval (average)
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) score
Description
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)
Time Frame
one day interval (average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Ho Kim, M.D.
Organizational Affiliation
Seoul Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Medical Center
City
Seoul
ZIP/Postal Code
135-740
Country
Korea, Republic of

12. IPD Sharing Statement

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