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
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Acute Pain Chronic Pain||Drug: Ketamine infusion Drug: NS infusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Placebo Comparator: C group
In C group, NS infusion will be done intraoperatively.
Drug: NS infusion
Normal saline will be infused intraoperatively.
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).
Drug: Ketamine infusion
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
- 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)
- 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.
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): NCT01997801
|Contact: Hee-Pyoung Park, PhDfirstname.lastname@example.org|
|Contact: Hyun-Chang Kim, MDemail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Hee-Pyoung Park, PhD +82-10-2971-7647 firstname.lastname@example.org|
|Contact: Hyun-Chang Kim, MD +82-10-2886-2876 email@example.com|
|Principal Investigator: Hee-Pyoung Park, PhD|
|Study Director:||Hee-Pyoung Park, PhD||Seoul National University of Hospital|