Effect of OFA in Laparoscopic Gastrectomy

Overview

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.

Full Title of Study: “Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 1, 2023

Interventions

  • Drug: 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.
  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: OFA group
    • 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.
  • Active Comparator: Control group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Opioid consumption in postoperative 24hrs
    • Time Frame: 24 hours after surgery
    • Total opioid dose administered to the patient.

Secondary Measures

  • Opioid consumption
    • Time Frame: postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days
    • Total opioid dose administered to the patient.
  • Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)
    • Time Frame: up to 2weeks
    • Time (hours) to first gas passing / starting oral fluid intake / starting soft diet
  • Pain score
    • Time Frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks
    • verbal numerical rating scale 0-10
  • Nausea score
    • Time Frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
    • verbal numerical rating scale 0-10
  • Time to rescue analgesics after surgery
    • Time Frame: up to 2weeks
    • Time (hours) to first rescue analgesics
  • Number of vomiting, antiemetic adeministration
    • Time Frame: up to 2weeks
    • Number of vomiting, antiemetic adeministration
  • Hemodynamics during surgery
    • Time Frame: during surgery
    • changes in hemodyanamics during surgery
  • QoR-15
    • Time Frame: postoperative 1day, 4day
    • Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)
  • PCL-5
    • Time Frame: postoperative 1week
    • Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)

Participating in This Clinical Trial

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.)

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gangnam Severance Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Young Song, Professor – Gangnam Severance Hospital

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