---
title: "Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant"
nct_id: NCT02819089
overall_status: UNKNOWN
phase: NA
sponsor: Mahidol University
study_type: INTERVENTIONAL
primary_condition: Cervical Spondylosis
countries: Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02819089.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02819089"
ct_last_update_post_date: 2016-06-30
last_seen_at: "2026-05-12T06:03:09.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant

**NCT ID:** [NCT02819089](https://clinicaltrials.gov/study/NCT02819089)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Mahidol University
- **Conditions:** Cervical Spondylosis
- **Start Date:** 2016-05
- **Completion Date:** 2018-04
- **CT.gov Last Update:** 2016-06-30

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Dexmedetomidine** (ACTIVE_COMPARATOR) — 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.
- **NSS** (PLACEBO_COMPARATOR) — NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

## Interventions

- **Dexmedetomidine** (DRUG) — 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.
- **NSS** (OTHER) — NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

## Primary Outcomes

- **Riker sedation agitation scores** _(time frame: 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 Outcomes

- **Fentanyl consumption** _(time frame: during surgery)_

## Locations (1)

- Siriraj Hospital, Mahidol University, Bangkoknoi, Bangkok, Thailand — _RECRUITING_

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.siriraj hospital, mahidol university|bangkoknoi|bangkok|thailand` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02819089*  
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