Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant

Study Overview
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Brief Summary
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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.

Official Title
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Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant

Conditions
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Cervical Spondylosis

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: NSS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Demedetomidine infusion (2mcg/ml); loading 0.5 mcg/kg for 30 min (BW/2 ml/h for 30 min), then 0.5 mcg/kg (BW/4 ml/h) until 30 minutes before finish the operation. | Drug: Dexmedetomidine<br>* Demedetomidine infusion (2mcg/ml); loading 0.5 mcg/kg for 30 min (BW/2 ml/h for 30 min), then 0.5 mcg/kg (BW/4 ml/h) until 30 minutes before finish the operation.<br>* Other names: Precedex;|
| Placebo Comparator: NSS<br>NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation. | Other: NSS<br>* NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.<br>* Other names: Narmal saline, 0.9%NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Riker sedation agitation scores | After finish the operation, Desflurane will be stopped. All patients will be received the neuromuscular reversal drugs and TOF ratio > 0.9. All patients will be evaluated by Riker sedation agitation score before extubation and re-evaluated again at 15 minutes after extubation. Riker sedation agitation scores Dangerous agitation: trying to get out of bed, pulling out tube, thrashing Very agitated: may require physical restraint, unable to calm with verbal instructions. Agitated: mild agitation and anxiety but calm down with verbal instructions. Calm and cooperative: aroused easily and follows commands Sedated: difficult to aroused, but does arouse to verbal or physical stimuli, able to follow simple commands Very sedated: does not follow commands but arouses to physical stimulation Unarousable: little or no response to noxious stimuli | before extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption | After finish the operation, the total of fentanyl consumption during the operation will be recorded. | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cervical spine surgery, ACDF, Dexmedetomidine, Anesthesia, Agitation, Riker sedation agitation scores