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

Sponsor

Nan Jiang (Other)

Overall Status

Unknown status

CT.gov ID

NCT03076099

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Dexmedetomidine Other: normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two parallel groupstwo parallel groups

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Dec 31, 2017

Arms and Interventions

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

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:

Outcome Measures

Primary Outcome Measures

urapidil consumption [the end of the 6th hour after tracheal extubation]
urapidil consumption was recorded by nurses every hour

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.