Clinical trial NCT02819089: Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant
Official title: Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spondylosis
Keywords: anterior cervical spine surgery
ACDF
Dexmedetomidine
Anesthesia
Agitation
Riker sedation agitation scores
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the recovery profiles after general anesthesia in patient undergoing anterior cervical spine surgery. This study will compare the Riker sedation agitation scores between two groups, with or without dexmedetomidine as an anesthetic adjuvant.


Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* elective case for ACDF surgery
* plan for extubation after surgery

Exclusion Criteria:

* SBP\>140 mmHg
* CAD
* HR\<50 BPM, heart block
* motor weakness \> grade 4
* BMI \>30
* allergic to dexmedetomidine, fentanyl

Primary outcomes:
measure: Riker sedation agitation scores
timeFrame: before extubation
Secondary outcomes:
measure: Fentanyl consumption
timeFrame: during surgery
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Department of Anesthesiology, Siriraj Hospital, Mahidol University
name: Busara Sirivanasandha, MD
role: PRINCIPAL_INVESTIGATOR
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