Ketamine in Robot-assisted Thyroidectomy (KEThyRobot)

Seoul National University

Status: Unknown

Conditions: Chronic Pain; Thyroid; Acute Pain

Treatments: Drug: Ketamine infusion; Drug: NS infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01997801

SNUH_KEThyRobot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

C group

Placebo Comparator group

Description:

In C group, NS infusion will be done intraoperatively.

Treatment:

Drug: NS infusion

KET group

Experimental group

Description:

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).

Treatment:

Drug: Ketamine infusion