Ketamine in Robot-assisted Thyroidectomy
KEThyRobot
The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 28, 2013
November 1, 2013
1 year
November 18, 2013
November 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain at 24 hour postoperatively
Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)
at 24 hour postoperatively
Secondary Outcomes (4)
Pain at 3, 6, 12, 48 and 72 hour postoperatively
at 3, 6, 12, 48 and 72 hour postoperatively
Time to the first analgesics postoperatively
At 24 hours postoperatively
Analgesic requirements for 24 hours after surgery
at 24 hours postoperatively
Chronic pain at 3 month after surgery
At 3 month after surgery
Study Arms (2)
C group
PLACEBO COMPARATORIn C group, NS infusion will be done intraoperatively.
KET group
EXPERIMENTALIn KET group, ketamine infusion will be done intraoperatively(0.25 mg/kg bolus injection following 100 mcg/kg/hr till the end of surgery).
Interventions
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
Eligibility Criteria
You may qualify if:
- Patients scheduled for robot-assisted thyroidectomy
- ASA I-III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 29124992DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hee-Pyoung Park, PhD
Seoul National University of Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 28, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 28, 2013
Record last verified: 2013-11