Effect of OFA in Laparoscopic Gastrectomy
- Conditions
- Postoperative Pain
- Interventions
- Drug: OFADrug: Control
- Registration Number
- NCT05076903
- Lead Sponsor
- Gangnam Severance Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OFA group OFA 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. Control group Control 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.
- Primary Outcome Measures
Name Time Method Opioid consumption in postoperative 24hrs 24 hours after surgery Total opioid dose administered to the patient.
- Secondary Outcome Measures
Name Time Method Time to rescue analgesics after surgery up to 2weeks Time (hours) to first rescue analgesics
Hemodynamics during surgery during surgery changes in hemodyanamics during surgery
PCL-5 postoperative 1week Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)
Nausea score postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days verbal numerical rating scale 0-10
Number of vomiting, antiemetic adeministration up to 2weeks Number of vomiting, antiemetic adeministration
Opioid consumption postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days Total opioid dose administered to the patient.
QoR-15 1-5 days before surgery, postoperative 1day, postoperative 4day Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)
Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time) up to 2weeks Time (hours) to first gas passing / starting oral fluid intake / starting soft diet
Pain score postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks verbal numerical rating scale 0-10
Trial Locations
- Locations (2)
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hsopital
🇰🇷Seoul, Korea, Republic of