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

NCT02819089 | Unknown DMC

• 1 other identifier: 018/2559(EC1)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  before extubation

Secondary Outcomes (1)

• Fentanyl consumption

  during surgery

Study Arms (2)

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.

Drug: Dexmedetomidine

NSS

PLACEBO COMPARATOR

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

Other: NSS

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.

Also known as: Precedex

Dexmedetomidine

NSS OTHER

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

Also known as: Narmal saline, 0.9%NaCl

NSS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (16)

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• Kim HS, Byon HJ, Kim JE, Park YH, Lee JH, Kim JT. Appropriate dose of dexmedetomidine for the prevention of emergence agitation after desflurane anesthesia for tonsillectomy or adenoidectomy in children: up and down sequential allocation. BMC Anesthesiol. 2015 May 27;15:79. doi: 10.1186/s12871-015-0059-z.

  PMID: 26012345 BACKGROUND

• Polat R, Peker K, Baran I, Bumin Aydin G, Topcu Guloksuz C, Donmez A. Comparison between dexmedetomidine and remifentanil infusion in emergence agitation during recovery after nasal surgery: A randomized double-blind trial. Anaesthesist. 2015 Oct;64(10):740-6. doi: 10.1007/s00101-015-0077-8. Epub 2015 Sep 2.

  PMID: 26329913 BACKGROUND

• Gopalakrishna KN, Dash PK, Chatterjee N, Easwer HV, Ganesamoorthi A. Dexmedetomidine as an Anesthetic Adjuvant in Patients Undergoing Transsphenoidal Resection of Pituitary Tumor. J Neurosurg Anesthesiol. 2015 Jul;27(3):209-15. doi: 10.1097/ANA.0000000000000144.

  PMID: 25493927 BACKGROUND

• Anjum N, Tabish H, Debdas S, Bani HP, Rajat C, Anjana Basu GD. Effects of dexmedetomidine and clonidine as propofol adjuvants on intra-operative hemodynamics and recovery profiles in patients undergoing laparoscopic cholecystectomy: A prospective randomized comparative study. Avicenna J Med. 2015 Jul-Sep;5(3):67-73. doi: 10.4103/2231-0770.160231.

  PMID: 26229757 BACKGROUND

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  PMID: 23887684 BACKGROUND

• Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia in Patients After Abdominal Colectomy: A Consort-Prospective, Randomized, Controlled Clinical Trial. Medicine (Baltimore). 2015 Sep;94(37):e1514. doi: 10.1097/MD.0000000000001514.

  PMID: 26376397 BACKGROUND

• Anastasian ZH, Gaudet JG, Levitt LC, Mergeche JL, Heyer EJ, Berman MF. Factors that correlate with the decision to delay extubation after multilevel prone spine surgery. J Neurosurg Anesthesiol. 2014 Apr;26(2):167-71. doi: 10.1097/ANA.0000000000000028.

  PMID: 24296539 BACKGROUND

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  PMID: 25293480 BACKGROUND

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  PMID: 22173570 BACKGROUND

• Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Colectomy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Medicine (Baltimore). 2015 Oct;94(43):e1727. doi: 10.1097/MD.0000000000001727.

  PMID: 26512563 BACKGROUND

MeSH Terms

Conditions

Spondylosis; Psychomotor Agitation

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Busara Sirivanasandha, MD

  Department of Anesthesiology, Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Busara Sirivanasandha, MD

CONTACT

+6624197990; busarasiri@yahoo.com

Manee Raksakietisak, MD

CONTACT

+6624127990; manee95@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 30, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)