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

Mahidol University

Status: Unknown

Conditions: Cervical Spondylosis

Treatments: Other: NSS; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02819089

018/2559(EC1)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

NSS

Placebo Comparator group

Description:

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

Treatment:

Other: NSS