Effect of OFA in Laparoscopic Gastrectomy

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Control; Drug: OFA

Study type: Interventional

Funder types: Other

Identifiers

NCT05076903

3-2021-0295

Details and patient eligibility

About

The investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. The investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption.

And investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. The investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption.

Enrollment: 120 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer

Exclusion criteria

• Patients with a history of allergic reactions to drugs
• Patients with a history of drug addiction
• Patients with chronic pain who require analgesics
• Patients with cancer other than the stomach
• History of hospitalization for psychiatric disorders
• Patients with sleep apnea
• Preoperative pulse oximetry (SpO2) < 95 %
• Moderate or severe hepatic impairment
• bradycardia (HR<50bpm), hypotension, atrioventricular block, intraventricular or sinus block
• Body mass index over 35 kg/m2
• Blood clotting disorders
• Pregnant/lactating women
• Cognitive impairment
• Unable to read consent form (eg illiterate, foreigner, etc.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

OFA group

Experimental group

Description:

Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.

Treatment:

Drug: OFA

Control group

Active Comparator group

Description:

Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.

Treatment:

Drug: Control