CClinicalTrials.gg
Status unknownNCT02819089Updated Jun 30, 2016

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

An interventional study of Dexmedetomidine and NSS in Cervical Spondylosis, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-30.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cervical Spondylosis

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Keywords

  • anterior cervical spine surgery
  • ACDF
  • Dexmedetomidine
  • Anesthesia
  • Agitation
  • Riker sedation agitation scores
03

In context

Spondylosis

144 studies on the registry are indexed under Spondylosis; 41 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 99 interventional studies indexed under Spondylosis.

Browse Spondylosis studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • SBP>140 mmHg
  • CAD
  • HR\<50 BPM, heart block
  • motor weakness > grade 4
  • BMI >30
  • allergic to dexmedetomidine, fentanyl
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

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.

    Also known as: Precedex

  • OtherNSS

    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

06

What researchers measure

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

    Time frame: before extubation

Secondary outcomes

  1. Fentanyl consumption

    After finish the operation, the total of fentanyl consumption during the operation will be recorded.

    Time frame: during surgery

07

Study locations

1 of 1 sites recruiting
  • Siriraj Hospital, Mahidol University
    Bangkoknoi, Bangkok 10700, Thailand
    Recruiting
08

References and documents

Publications

  • Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2. PubMed 16670111 ↗
  • Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5. PubMed 20526708 ↗
  • Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. doi: 10.1046/j.1365-2044.1999.00659.x. PubMed 10215710 ↗
  • Maze M, Scarfini C, Cavaliere F. New agents for sedation in the intensive care unit. Crit Care Clin. 2001 Oct;17(4):881-97. doi: 10.1016/s0749-0704(05)70185-8. PubMed 11762266 ↗
  • 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. PubMed 26012345 ↗
  • 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. PubMed 26329913 ↗
  • 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. PubMed 25493927 ↗
  • 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. PubMed 26229757 ↗
  • Mariappan R, Ashokkumar H, Kuppuswamy B. Comparing the effects of oral clonidine premedication with intraoperative dexmedetomidine infusion on anesthetic requirement and recovery from anesthesia in patients undergoing major spine surgery. J Neurosurg Anesthesiol. 2014 Jul;26(3):192-7. doi: 10.1097/ANA.0b013e3182a2166f. PubMed 23887684 ↗
  • 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. PubMed 26376397 ↗
  • 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. PubMed 24296539 ↗
  • Cavallone LF, Vannucci A. Review article: Extubation of the difficult airway and extubation failure. Anesth Analg. 2013 Feb;116(2):368-83. doi: 10.1213/ANE.0b013e31827ab572. Epub 2013 Jan 9. PubMed 23302983 ↗
  • Karwacki Z, Niewiadomski S, Rzaska M, Witkowska M. The effect of bispectral index monitoring on anaesthetic requirements in target-controlled infusion for lumbar microdiscectomy. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):284-8. doi: 10.5603/AIT.2014.0046. PubMed 25293480 ↗
  • Tsai CJ, Chu KS, Chen TI, Lu DV, Wang HM, Lu IC. A comparison of the effectiveness of dexmedetomidine versus propofol target-controlled infusion for sedation during fibreoptic nasotracheal intubation. Anaesthesia. 2010 Mar;65(3):254-9. doi: 10.1111/j.1365-2044.2009.06226.x. Epub 2010 Jan 22. PubMed 20105150 ↗
  • Terao Y, Ichinomiya T, Higashijima U, Tanise T, Miura K, Fukusaki M, Sumikawa K. Comparison between propofol and dexmedetomidine in postoperative sedation after extensive cervical spine surgery. J Anesth. 2012 Apr;26(2):179-86. doi: 10.1007/s00540-011-1300-7. Epub 2011 Dec 16. PubMed 22173570 ↗
  • 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. PubMed 26512563 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02819089
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
May 2016
Primary completion
Apr 2018 (estimated)
Completion
Apr 2018 (estimated)
Last update
Jun 30, 2016

Study contacts

Busara Sirivanasandha, MD
Contact
busarasiri@yahoo.com
+6624197990
Manee Raksakietisak, MD
Contact
manee95@hotmail.com
+6624127990
Busara Sirivanasandha, MD
principal investigator · Department of Anesthesiology, Siriraj Hospital, Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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