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

NCT ID: NCT01884298

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Postoperative Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

patients with isolated systolic hypertension

patients combined with isolated systolic hypertension undergoing abdominal surgery

Group Type: EXPERIMENTAL

remifentanil(Ultiva)

Intervention Type: DRUG

remifentanil (TCI, Ce 3 ng /ml)for intra-operative analgesia

epidural infusing 2% lidocaine

Intervention Type: DRUG

epidural infusing 2% lidocaine 4ml bolus followed by 6-18ml/hr for intra-operative analgesia

Interventions

remifentanil(Ultiva)

remifentanil (TCI, Ce 3 ng /ml)for intra-operative analgesia

Intervention Type: DRUG

epidural infusing 2% lidocaine

epidural infusing 2% lidocaine 4ml bolus followed by 6-18ml/hr for intra-operative analgesia

Intervention Type: DRUG

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZhouYan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dongxin Wang, MD

Role: STUDY_CHAIR

PKU 1st hospital

Locations

PKU 1st hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

EPIISO-021

Identifier Type: -

Identifier Source: org_study_id