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

NCT03076099 | Unknown DMC

• 1 other identifier: NJiang2016-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Keywords

Dexmedetomidine; brain arteriovenous malformation; embolization; post-operative hypertension

Outcome Measures

Primary Outcomes (1)

• urapidil consumption

  urapidil consumption was recorded by nurses every hour

  the end of the 6th hour after tracheal extubation

Secondary Outcomes (17)

• urapidil consumption on POD1

  the total consumption of urapidil on post-operative day 1.

• urapidil consumption on POD2

  the total consumption of urapidil on post-operative day 2.

• Visual Analogue score

  the end of the 6th hour after tracheal extubation

• Visual Analogue score at 24th hour

  the end of the 24th hour after tracheal extubation

• Visual Analogue score at 48th hour

  the end of the 48th hour after tracheal extubation

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

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.

Other: normal saline

Interventions

Dexmedetomidine DRUG

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

Also known as: DEX

Dexmedetomidine

normal saline OTHER

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

Also known as: NS

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nan Jiang: lead

Study Sites (1)

the First Affiliated Hospital of Sun Yetsen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Nan Jiang, PhD

CONTACT

86 20 28823350; NJiang_sysu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: this investigation is a triple mask study. The patiens, the care providers and Outcome Assessor will not allowed to know the grouping information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Model Details: two parallel groups

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)