Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

Urogynecology Clinical Trial

Official title:

Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757484
• Other study ID #: 25003
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: December 15, 2015
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: May 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to establish normal postoperative changes in blood pressure in women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also, to establish if there is a difference in normal postoperative blood pressure changes between elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient postoperative care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women who underwent scheduled gynecologic surgery requiring inpatient postoperative care between January 2007 - January 2008

Exclusion Criteria:

• Women who experienced myocardial infarction, cardiac arrest or failure, pulmonary embolism, infection requiring intravenous antibiotics, intra- or postoperative hemorrhage requiring blood transfusion, renal failure

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Urogynecology

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Underwent Gynecologic Surgery	491 women were included in analysis. Measure is categorized by the type of surgery.	January 2007 to January 2008	No
Secondary	Percentage of Women With Asymptomatic Hypotension	% women with asymptomatic hypotension	1 year	No
Secondary	Percentage of Participants Undergoing Different Types of Anesthesia	Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).	January 2007 to January 2008	No
Secondary	Surgical Time	Length of surgery	January 2007 to January 2008	No