Clinical trial NCT01997801: Ketamine in Robot-assisted Thyroidectomy
Official title: The Efficacy of Intraoperative Ketamine in Patients Undergoing Robot-assisted Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid
Acute Pain
Chronic Pain
Keywords: Thyroidectomy
Endoscopy
Ketamine
Acute Pain
Chronic Pain
Postoperative period
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain at 24 hour postoperatively
timeFrame: at 24 hour postoperatively
Secondary outcomes:
measure: Pain at 3, 6, 12, 48 and 72 hour postoperatively
timeFrame: at 3, 6, 12, 48 and 72 hour postoperatively
measure: Time to the first analgesics postoperatively
timeFrame: At 24 hours postoperatively
measure: Analgesic requirements for 24 hours after surgery
timeFrame: at 24 hours postoperatively
measure: Chronic pain at 3 month after surgery
timeFrame: At 3 month after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Hee-Pyoung Park, PhD
role: STUDY_DIRECTOR
References:
citation: 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.