Ketamine in Robot-assisted Thyroidectomy

Not Applicable

• Conditions: Acute Pain; Thyroid; Chronic Pain
• Interventions: Drug: NS infusion; Drug: Ketamine infusion

• Registration Number: NCT01997801
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-24
• Last Update Submitted: 2013-11-24
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28
• Study Start: 2013-12
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C group	NS infusion	In C group, NS infusion will be done intraoperatively.
KET group	Ketamine infusion	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).

Primary Outcome Measures

Name	Time	Method
Pain at 24 hour postoperatively	at 24 hour postoperatively	Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable)

Secondary Outcome Measures

Name	Time	Method
Chronic pain at 3 month after surgery	At 3 month after surgery	Chronic pain at 3 month after surgery will be evaluated.
Analgesic requirements for 24 hours after surgery	at 24 hours postoperatively	Analgesic requirements for 24 hours after surgery will be evaluated.
Pain at 3, 6, 12, 48 and 72 hour postoperatively	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	At 24 hours postoperatively	Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of