Target Effect-site Concentration of Remifentanil in Transperineal Prostate Puncture

February 4, 2018 updated by: Chinese Medical Association

The Research About the Target Effect-site Concentration of Remifentanil Inhibiting Stress Reaction of the Perineal Prostate Puncture When Dexmedetomidine Being Continuous Pumping

The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients who were scheduled to undergo transperineal prostate puncture and biopsy were recruited into our study. In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. The first target effect-site concentration of remifentanil was set to 4.5ng/ml, the difference of adjacent target concentration was 0.5 ng/ml. Cardiovascular positive reaction was defined as the changes of heart rate or systolic blood pressure was more than 15% compared with baseline values, or body movement observed. The adjacent target concentration difference was adjusted to 0.2 ng/ml after 3 negative and positive reaction cycles. If the first had a cardiovascular positive reaction, the target concentration of remifentanil increased by a concentration gradient. Conversely, the target concentration of remifentanil decreased by a concentration gradient.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
          • Yi Liu
          • Phone Number: 13386277602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

patients of perineal prostate puncture

Description

Inclusion Criteria:

  • patients of perineal prostate puncture

Exclusion Criteria:

  • sinus bradycardia or atrioventricular block serious heart, brain, lung, liver, kidney, and metabolic disease allergy for dexmedetomidine or opioid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the target effect-site concentration of remifentanil
Time Frame: intraoperative
the target Effect-site concentration of remifentanil was determined by sequential method.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Medical Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 4, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 4, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAC-0109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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