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Clinical Trials/NCT05076903
NCT05076903
Completed
Not Applicable

Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait

Gangnam Severance Hospital2 sites in 1 country120 target enrollmentSeptember 14, 2021
InterventionsOFAControl

Overview

Phase
Not Applicable
Intervention
OFA
Conditions
Postoperative Pain
Sponsor
Gangnam Severance Hospital
Enrollment
120
Locations
2
Primary Endpoint
Opioid consumption in postoperative 24hrs
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2021
End Date
November 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Song

Professor

Gangnam Severance Hospital

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: OFA

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.

Intervention: Control

Outcomes

Primary Outcomes

Opioid consumption in postoperative 24hrs

Time Frame: 24 hours after surgery

Total opioid dose administered to the patient.

Secondary Outcomes

  • Time to rescue analgesics after surgery(up to 2weeks)
  • Hemodynamics during surgery(during surgery)
  • PCL-5(postoperative 1week)
  • Nausea score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days)
  • Number of vomiting, antiemetic adeministration(up to 2weeks)
  • Opioid consumption(postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days)
  • QoR-15(1-5 days before surgery, postoperative 1day, postoperative 4day)
  • Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)(up to 2weeks)
  • Pain score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks)

Study Sites (2)

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