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

Cervical Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02819089
• Other study ID #: 018/2559(EC1)
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 27, 2016
• Start date: May 2016
• Est. completion date: April 2018

Study information

• Verified date: June 2016
• Source: Mahidol University
• Contact: Busara Sirivanasandha, MD
• Phone: +6624197990
• Email: busarasiri[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. Review. — View Citation

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. — View Citation

Lepousé 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. Epub 2006 May 2. — View Citation

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. — View Citation

Maze M, Scarfini C, Cavaliere F. New agents for sedation in the intensive care unit. Crit Care Clin. 2001 Oct;17(4):881-97. Review. — View Citation

Polat R, Peker K, Baran I, Bumin Aydin G, Topçu Gülöksüz Ç, Dönmez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; Dangerous agitation: trying to get out of bed, pulling out tube, thrashing; Very agitated: may require physical restraint, unable to calm with verbal instructions.; Agitated: mild agitation and anxiety but calm down with verbal instructions.; Calm and cooperative: aroused easily and follows commands; Sedated: difficult to aroused, but does arouse to verbal or physical stimuli, able to follow simple commands; Very sedated: does not follow commands but arouses to physical stimulation; Unarousable: little or no response to noxious stimuli	before extubation	Yes
Secondary	Fentanyl consumption	After finish the operation, the total of fentanyl consumption during the operation will be recorded.	during surgery	Yes