Hypokalemia and Intravenous Patient Controlled Analgesia

NCT ID: NCT01269099

Last Updated: 2011-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

General Anesthesia Laparoscopic Cholecystectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Control-group

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

control group (No-PCA group)

IV-PCA

IV-PCA group

Group Type EXPERIMENTAL

IV-PCA

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV-PCA

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

Intervention Type DRUG

Control

control group (No-PCA group)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fentanyl no drug

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seoul Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Won Ho Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMC-2010-01-24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre-op Fluid Study
NCT05079269 ACTIVE_NOT_RECRUITING NA