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

Not Applicable

• Conditions: Cervical Spondylosis
• Interventions: Other: NSS; Drug: Dexmedetomidine

• Registration Number: NCT02819089
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSS	NSS	NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.
Dexmedetomidine	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Riker sedation agitation scores	before extubation	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; 1. Dangerous agitation: trying to get out of bed, pulling out tube, thrashing; 2. Very agitated: may require physical restraint, unable to calm with verbal instructions.; 3. Agitated: mild agitation and anxiety but calm down with verbal instructions.; 4. Calm and cooperative: aroused easily and follows commands; 5. Sedated: difficult to aroused, but does arouse to verbal or physical stimuli, able to follow simple commands; 6. Very sedated: does not follow commands but arouses to physical stimulation; 7. Unarousable: little or no response to noxious stimuli

Secondary Outcome Measures

Name	Time	Method
Fentanyl consumption	during surgery	After finish the operation, the total of fentanyl consumption during the operation will be recorded.

Trial Locations

Locations (1)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand