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

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ClinicalTrials.gov Identifier: NCT02819089
Recruitment Status : Unknown
Verified June 2016 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Spondylosis Drug: Dexmedetomidine Other: NSS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant
Study Start Date : May 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: Precedex

Placebo Comparator: NSS
NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.
Other: NSS
NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.
Other Name: Narmal saline, 0.9%NaCl




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Fentanyl consumption [ Time Frame: during surgery ]
    After finish the operation, the total of fentanyl consumption during the operation will be recorded.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819089


Contacts
Contact: Busara Sirivanasandha, MD +6624197990 busarasiri@yahoo.com
Contact: Manee Raksakietisak, MD +6624127990 manee95@hotmail.com

Locations
Thailand
Siriraj Hospital, Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Busara Sirirvanadandha, MD    +66851429656    busarasiri@yahoo.com   
Contact: Manee Raksakietisak, MD    +668-1488-0620    manee95@hotmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Busara Sirivanasandha, MD Department of Anesthesiology, Siriraj Hospital, Mahidol University

Publications:

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02819089     History of Changes
Other Study ID Numbers: 018/2559(EC1)
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mahidol University:
anterior cervical spine surgery
ACDF
Dexmedetomidine
Anesthesia
Agitation
Riker sedation agitation scores

Additional relevant MeSH terms:
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action