Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study

NCT02244177 | Unknown

• 1 other identifier: VGHKS-103-080
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Pain

  Post-operation Day1 to Day4

Secondary Outcomes (1)

• Morphine consumption

  Post-operation Day1 to Day4

Other Outcomes (1)

• side effects

  Post-operation Day1 to Day4

Study Arms (3)

normotension group

Until 11,March, 2015, 31 cases are collected.

hypertension group without treatment

Until 11,March, 2015, 60 cases are collected.

hypertension group with antihypertensive treatment

(ACEI, beta-blocker, Ca blocker, Diuretics) prior to the surgery. Until 11,March, 2015, 59 cases are collected.

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those patients enrolled will be divided into three groups as follows As the treatment and choice of drugs for hypertension is complex but internation guideline-oriented. We would like to enroll enough sample size in the hypertensive groups and subgroups. 1. Normaltension group (control group) 2. Hypertension without treatment 3. Hypertension with treatment as follows (according to subject's daily routine Tx, the PI not involved into the choice and further manitence of drugs) I. Hypertension with treatment with ACEI II. Hypertension with treatment with β blocker III. Hypertension with treatment with Ca channel blocker IV. Hypertension with treatment with diuretics

You may qualify if:

• eligible subjects
• No contraindication for inhalation anesthesia
• Elective surgery
• Age between 20-75 y/o
• No contraindication for postoperative morphine pain control
• Female or male
• Essential hypertension stage I and II (140\<=SBP\<=180; 90\<=DBP\<=110)

You may not qualify if:

• Liver disease
• Renal disease
• Those who is presumed to go to ICU after surgery
• The patients with dementia or conscious disturbance
• Pregnancy or breast feeding
• Secondary hypertension
• events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina cerebrovascular events congestive heart failure significant arrhythmia thoracic surgery

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuan Yi Chia, Bachelor

CONTACT

88673468183; yychia@isca.vghks.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesia doctor

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 18, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

TW (1)