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Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remifentanil(Ultiva)
epidural infusing 2% lidocaine
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring remifentanil, isolated systolic hypertension, morbidity, epidural combined general anesthesia

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- adults aged 50-70 with isolated systolic hypertension .

Exclusion Criteria:

  • age < 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 < 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine > 50% or liver enzymes > 50% upper limit of normal values)

Sites / Locations

  • PKU 1st hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with isolated systolic hypertension

Arm Description

patients combined with isolated systolic hypertension undergoing abdominal surgery

Outcomes

Primary Outcome Measures

Length of postoperative hospital stay
cardiovascular morbidity
respiratory morbidity
postoperative renal failure

Secondary Outcome Measures

Full Information

First Posted
June 19, 2013
Last Updated
June 21, 2013
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01884298
Brief Title
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity
Official Title
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and morbidity---a Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. however, the epidural technique often causes more drop of blood pressure, especially in dehydrated patients. The investigators designed the trial to see if the benefit weigh out the potential risk of epidural in isolated hypertensive patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
remifentanil, isolated systolic hypertension, morbidity, epidural combined general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with isolated systolic hypertension
Arm Type
Experimental
Arm Description
patients combined with isolated systolic hypertension undergoing abdominal surgery
Intervention Type
Drug
Intervention Name(s)
remifentanil(Ultiva)
Intervention Description
remifentanil (TCI, Ce 3 ng /ml)for intra-operative analgesia
Intervention Type
Drug
Intervention Name(s)
epidural infusing 2% lidocaine
Intervention Description
epidural infusing 2% lidocaine 4ml bolus followed by 6-18ml/hr for intra-operative analgesia
Primary Outcome Measure Information:
Title
Length of postoperative hospital stay
Time Frame
5 weeks
Title
cardiovascular morbidity
Time Frame
2 weeks
Title
respiratory morbidity
Time Frame
2 weeks
Title
postoperative renal failure
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - adults aged 50-70 with isolated systolic hypertension . Exclusion Criteria: age < 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 < 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine > 50% or liver enzymes > 50% upper limit of normal values)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongxin Wang, MD
Organizational Affiliation
PKU 1st hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PKU 1st hospital
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

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Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity

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