Ketamine in Robot-assisted Thyroidectomy

Chronic Pain Clinical Trial

— KEThyRobot  

Official title:

The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01997801
• Other study ID #: SNUH_KEThyRobot
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 24, 2013
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Seoul National University Hospital
• Contact: Hee-Pyoung Park, PhD
• Phone: +82-10-2971-7647
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Thyroid

Intervention

Drug:
• Ketamine infusion
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
• NS infusion
Normal saline will be infused intraoperatively.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain 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)	at 3, 6, 12, 48 and 72 hour postoperatively	No
Secondary	Time to the first analgesics postoperatively	Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.	At 24 hours postoperatively	No
Secondary	Analgesic requirements for 24 hours after surgery	Analgesic requirements for 24 hours after surgery will be evaluated.	at 24 hours postoperatively	No
Secondary	Chronic pain at 3 month after surgery	Chronic pain at 3 month after surgery will be evaluated.	At 3 month after surgery	No