NCT01884298

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

July 2, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2015

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

June 19, 2013

Last Update Submit

May 16, 2026

Conditions

Postoperative Complications

Keywords

remifentanilisolated systolic hypertensionmorbidityepidural combined general anesthesia

Outcome Measures

Primary Outcomes (4)

  • Length of postoperative hospital stay

    days

    5 weeks

  • cardiovascular morbidity

    case

    2 weeks

  • respiratory morbidity

    case

    2 weeks

  • postoperative renal failure

    case

    2 weeks

Study Arms (2)

patients receive either epidural or non epidural depends on doctor responsible

epidural or non epidural

patients receive epidural depends on doctor responsible

patients receive non epidural depends on doctor responsible

Interventions

remifentanil(Ultiva)
epidural infusing 2% lidocaine

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults aged 50-70 with isolated systolic hypertension .

You may qualify if:

  • \- adults aged 50-70 with isolated systolic hypertension .

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PKU 1st hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Postoperative ComplicationsIsolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEssential HypertensionHypertensionVascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 24, 2013

Study Start

July 2, 2013

Primary Completion

December 2, 2015

Study Completion

December 2, 2015

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

CN(1)