Effect of OFA in Laparoscopic Gastrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: OFA; Drug: Control

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hsopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in postoperative 24hrs	Total opioid dose administered to the patient.	24 hours after surgery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety Depression Scale	Score of HADS questionnaire (Hospital Anxiety Depression Scale). It consists of 14 items and each item is scored on a scale of 0-3.	1-5 days before surgery
Euro Quality of Life - 5 Dimensions	Score of EQ-5D-5L questionnaire (Five-level version of Euro Quality of Life - 5 Dimensions). It consists of 5 items, and each item is scored on a scale of 1-5.	1-5 days before surgery
Patient Health Questionnaire	Score of PHQ-15 questionnaire (Patient Health Questionnaire-15). It consists of 15 items, and each item is scored on a scale of 0-2.	1-5 days before surgery
Pain Catastrophizing Scale	Score of PCS questionnaire (Pain Catastrophizing Scale). It consists of 13 items, and each item is scored on a scale of 0-4.	1-5 days before surgery
Big Five Inventory-10	Score of BFI-10 questionnaire (Big Five Inventory-10). It consists of 10 items, and each item is scored on a scale of 1-5.	1-5 days before surgery
Hamilton Depression Rating Scale	Score of HAM-D (Hamilton Depression Rating Scale) examination. It consists of 17 items to evalulate depression, and higher scores indicate more severe depression.	1-5 days before surgery
Hamilton Anxiety Rating Scale	Score of HAM-A (Hamilton Anxiety Rating Scale) examination. It consists of 14 items to evalulate anxiety, and higher scores indicate more severe anxiety.	1-5 days before surgery
PainDETECT	Score of PainDETECT questionnaire. It consists of items such as the quality of pain, the pattern of pain, and higher scores indicate more severe neuropathic pain.	1-5 days before surgery
Temporal pain summation	Compare the pain after a single stimulation with the pain after 10 repeated stimulations.	1-5 days before surgery
Pressure pain threshold	The lowest pressure at which the participant perceives pain. It is measured by pressure algometry.	1-5 days before surgery
Pressure pain tolerance	The highest pressure when the participant perceived untolerable pain. It is measured by pressure algometry.	1-5 days before surgery
Frontal Electroencephalogram	Band power and connectivity in electroencephalogram	perioperative period
Analgesia Nociception Index (ANI)	Analgesia Nociception Index (ANI) from ANI monitoring	perioperative period

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 3-2021-0295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No