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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02819089

Enrollment

100

Registered

2016-06-30

Start date

2016-05-31

Completion date

2018-04-30

Last updated

2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spondylosis

Keywords

anterior cervical spine surgery, ACDF, Dexmedetomidine, Anesthesia, Agitation, Riker sedation agitation scores

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.

Interventions

DRUGDexmedetomidine

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.

OTHERNSS

NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Fentanyl consumption	during surgery	After finish the operation, the total of fentanyl consumption during the operation will be recorded.

Countries

Thailand

Contacts

Primary ContactBusara Sirivanasandha, MD

busarasiri@yahoo.com+6624197990

Backup ContactManee Raksakietisak, MD

manee95@hotmail.com+6624127990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026