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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076099
• Other study ID #: NJiang2016-001
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2017
• Last updated: March 6, 2017
• Start date: January 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2017
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Nan Jiang, PhD
• Phone: 86 20 28823350
• Email: NJiang_sysu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma

Intervention

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

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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Sun Yetsen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nan Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urapidil consumption	urapidil consumption was recorded by nurses every hour	the end of the 6th hour after tracheal extubation
Secondary	urapidil consumption on POD1	urapidil consumption was recorded by nurses every hour	the total consumption of urapidil on post-operative day 1.
Secondary	urapidil consumption on POD2	urapidil consumption was recorded by nurses every hour	the total consumption of urapidil on post-operative day 2.
Secondary	Visual Analogue score	visual analogue score was measured by visual analogue scale	the end of the 6th hour after tracheal extubation
Secondary	Visual Analogue score at 24th hour	visual analogue score was measured by visual analogue scale	the end of the 24th hour after tracheal extubation
Secondary	Visual Analogue score at 48th hour	visual analogue score was measured by visual analogue scale	the end of the 48th hour after tracheal extubation
Secondary	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
Secondary	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
Secondary	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
Secondary	Analgesics consumption	Analgesics consumption was recorded by nurse every hour	the end of the 6th hour after tracheal extubation
Secondary	Analgesics consumption on POD1	Analgesics consumption was recorded by nurse every hour	the total consumption of urapidil on post-operative day 1.
Secondary	Analgesics consumption on POD2	Analgesics consumption was recorded by nurse every hour	the total consumption of urapidil on post-operative day 2.
Secondary	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
Secondary	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
Secondary	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
Secondary	PONV	post-operative nausea and vomiting (PONV) was recorded by nurse	the end of the 6th hour after tracheal extubation
Secondary	PONV at 24th hour	post-operative nausea and vomiting (PONV) was recorded by nurse	the end of the 24th hour after tracheal extubation
Secondary	PONV at 48th hour	post-operative nausea and vomiting (PONV) was recorded by nurse	the end of the 48th hour after tracheal extubation