NCT03428191

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

January 25, 2018

Last Update Submit

February 4, 2018

Conditions

Anesthesia, Intravenous

Keywords

dexmedetomidineremifentanilprostate puncture and biopsy

Outcome Measures

Primary Outcomes (1)

  • the target effect-site concentration of remifentanil

    the target Effect-site concentration of remifentanil was determined by sequential method.

    intraoperative

Interventions

Remifentanyl+DexmedetomidineDRUG

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.

Also known as: target effect-site concentration of remifentanil

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of perineal prostate puncture

You may qualify if:

  • patients of perineal prostate puncture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

  • Liu Yi, D.M

    Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433

    STUDY DIRECTOR

Central Study Contacts

Yi Zhou

CONTACT

13761293168littlebaby89@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 9, 2018

Study Start

January 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 9, 2018

Record last verified: 2017-02

Locations

CN(1)