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

Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Other: normal saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nan Jiang, PhD; Phone Number: 86 20 28823350; Email: NJiang_sysu@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • the First Affiliated Hospital of Sun Yetsen University
      • Contact: Yi Liu, Master; Phone Number: +86 13632391455; Email: liuyisysu@126.com
      • Contact: Nan Jiang, professor; Phone Number: +86 20 28823350; Email: NJiang_sysu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; 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; 1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.; Other Names: DEX
Placebo Comparator: 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.	Other: normal saline; equal volume of normal saline was administered intravenously constantly after tracheal extubation.; Other Names: NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urapidil consumption	urapidil consumption was recorded by nurses every hour	the end of the 6th hour after tracheal extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urapidil consumption on POD1	urapidil consumption was recorded by nurses every hour	the total consumption of urapidil on post-operative day 1.
urapidil consumption on POD2	urapidil consumption was recorded by nurses every hour	the total consumption of urapidil on post-operative day 2.
Visual Analogue score	visual analogue score was measured by visual analogue scale	the end of the 6th hour after tracheal extubation
Visual Analogue score at 24th hour	visual analogue score was measured by visual analogue scale	the end of the 24th hour after tracheal extubation
Visual Analogue score at 48th hour	visual analogue score was measured by visual analogue scale	the end of the 48th hour after tracheal extubation
Quality of Recovery Score	Quality of Recovery Score was measured by a 15-item quality of recovery scale	the end of the 6th hour after tracheal extubation
Quality of Recovery Score at 24th hour	Quality of Recovery Score was measured by a 15-item quality of recovery scale	the end of the 24th hour after tracheal extubation
Quality of Recovery Score at 48th hour	Quality of Recovery Score was measured by a 15-item quality of recovery scale	the end of the 48th hour after tracheal extubation
Analgesics consumption	Analgesics consumption was recorded by nurse every hour	the end of the 6th hour after tracheal extubation
Analgesics consumption on POD1	Analgesics consumption was recorded by nurse every hour	the total consumption of urapidil on post-operative day 1.
Analgesics consumption on POD2	Analgesics consumption was recorded by nurse every hour	the total consumption of urapidil on post-operative day 2.
Bradycardia	a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse	the end of the 6th hour after tracheal extubation
Bradycardia at 24th hour	a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse	the end of the 24th hour after tracheal extubation
Bradycardia at 48th hour	a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse	the end of the 48th hour after tracheal extubation
PONV	post-operative nausea and vomiting (PONV) was recorded by nurse	the end of the 6th hour after tracheal extubation
PONV at 24th hour	post-operative nausea and vomiting (PONV) was recorded by nurse	the end of the 24th hour after tracheal extubation
PONV at 48th hour	post-operative nausea and vomiting (PONV) was recorded by nurse	the end of the 48th hour after tracheal extubation

Collaborators and Investigators

• Sponsor: Nan Jiang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Dexmedetomidine; embolization; brain arteriovenous malformation; post-operative hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cardiovascular Abnormalities; Vascular Malformations; Congenital Abnormalities; Arteriovenous Malformations; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: NJiang2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the IPD will not be shared with others, since following investigations based on this trial is about to start.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No