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Ketamine in Robot-assisted Thyroidectomy (KEThyRobot)

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ClinicalTrials.gov Identifier: NCT01997801
Recruitment Status : Unknown
Verified November 2013 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE November 28, 2013
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2013)
Pain at 24 hour postoperatively [ Time Frame: at 24 hour postoperatively ]
Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2013)
  • Pain at 3, 6, 12, 48 and 72 hour postoperatively [ Time Frame: at 3, 6, 12, 48 and 72 hour postoperatively ]
    Pain at 3, 6, 12, 48 and 72 hour postoperatively will be evaluated using 11-point scale 0:no pain, 10:worst imaginable)
  • Time to the first analgesics postoperatively [ Time Frame: At 24 hours postoperatively ]
    Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.
  • Analgesic requirements for 24 hours after surgery [ Time Frame: at 24 hours postoperatively ]
    Analgesic requirements for 24 hours after surgery will be evaluated.
  • Chronic pain at 3 month after surgery [ Time Frame: At 3 month after surgery ]
    Chronic pain at 3 month after surgery will be evaluated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine in Robot-assisted Thyroidectomy
Official Title  ICMJE The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
Brief Summary In this prospective double-blinded study, The investigators compared acute postoperative pain and rescue analgesic demand during postoperative period after robot thyroidectomy between ketamine and placebo groups.
Detailed Description Robot-assisted endoscopic thyroidectomy has been popularized due to cosmetic advantages. Despite small incisions, robot thyroidectomy did not offer satisfactory reduction in postoperative pain compared to open thyroidectomy. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor blocker and takes some attractive advantages in terms of pain control. When low dose ketamine is perioperatively administrated, opioid sparing effect during postoperative period is reported in various surgical procedures such as spine, thoracic, and gynecologic surgery. Ketamine's beneficial effect on postoperative pain has not been investigated in patients undergoing robot thyroidectomy. The investigators hypothesized that perioperative ketamine administration can reduce acute postoperative pain after robot thyroidectomy and the incidence of chronic pain hypoesthesia on anterior chest at 3 months after surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Thyroid
  • Acute Pain
  • Chronic Pain
Intervention  ICMJE
  • Drug: Ketamine infusion
    Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
  • Drug: NS infusion
    Normal saline will be infused intraoperatively.
Study Arms  ICMJE
  • Placebo Comparator: C group
    In C group, NS infusion will be done intraoperatively.
    Intervention: Drug: NS infusion
  • Experimental: KET group
    In KET group, ketamine infusion will be done intraoperatively(0.25 mg/kg bolus injection following 100 mcg/kg/hr till the end of surgery).
    Intervention: Drug: Ketamine infusion
Publications * Lee J, Park HP, Jeong MH, Son JD, Kim HC. Efficacy of ketamine for postoperative pain following robotic thyroidectomy: A prospective randomised study. J Int Med Res. 2018 Mar;46(3):1109-1120. doi: 10.1177/0300060517734679. Epub 2017 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 24, 2013)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for robot-assisted thyroidectomy
  • ASA I-III

Exclusion Criteria:

  • Patients with renal dysfunction
  • Patients with hepatic dysfunction
  • Patients with neurologic dysfunction
  • Patients with the history of drug addiction
  • Patients with chronic pain
  • Patients who are allergic to ketamine
  • Patients with increased ocular or intracranial pressure
  • Patients with the risk of aspiration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01997801
Other Study ID Numbers  ICMJE SNUH_KEThyRobot
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hee-Pyoung Park, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hee-Pyoung Park, PhD Seoul National University of Hospital
PRS Account Seoul National University Hospital
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP