Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization

NCT ID: NCT03076099

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-12-31

Brief Summary

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Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.

Detailed Description

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Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two parallel groups
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
this investigation is a triple mask study. The patiens, the care providers and Outcome Assessor will not allowed to know the grouping information.

Study Groups

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Dexmedetomidine

Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.

Control group

Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

equal volume of normal saline was administered intravenously constantly after tracheal extubation.

Interventions

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Dexmedetomidine

1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.

Intervention Type DRUG

normal saline

equal volume of normal saline was administered intravenously constantly after tracheal extubation.

Intervention Type OTHER

Other Intervention Names

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DEX NS

Eligibility Criteria

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Inclusion Criteria

* patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.

Exclusion Criteria

* abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nan Jiang

OTHER

Sponsor Role lead

Responsible Party

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Nan Jiang

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the First Affiliated Hospital of Sun Yetsen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Jiang, PhD

Role: CONTACT

86 20 28823350

Facility Contacts

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Yi Liu, Master

Role: primary

+86 13632391455

Nan Jiang, professor

Role: backup

+86 20 28823350

Other Identifiers

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NJiang2016-001

Identifier Type: -

Identifier Source: org_study_id

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