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Completed

NCT Number: NCT05076903

Effect of OFA in Laparoscopic Gastrectomy

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

OFA

Drug

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

Drug

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 outcomes

  1. Opioid consumption in postoperative 24hrs

    Time frame: 24 hours after surgery

    Total opioid dose administered to the patient.

Secondary outcomes

  1. Opioid consumption

    Time frame: postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days

    Total opioid dose administered to the patient.

  2. 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

  3. Pain score

    Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks

    verbal numerical rating scale 0-10

  4. Nausea score

    Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days

    verbal numerical rating scale 0-10

  5. Time to rescue analgesics after surgery

    Time frame: up to 2weeks

    Time (hours) to first rescue analgesics

  6. Number of vomiting, antiemetic adeministration

    Time frame: up to 2weeks

    Number of vomiting, antiemetic adeministration

  7. Hemodynamics during surgery

    Time frame: during surgery

    changes in hemodyanamics during surgery

  8. QoR-15

    Time frame: 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.)

  9. 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.)

Other outcomes

  1. Hospital Anxiety Depression Scale

    Time frame: 1-5 days before surgery

    Score of HADS questionnaire (Hospital Anxiety Depression Scale). It consists of 14 items and each item is scored on a scale of 0-3.

  2. Euro Quality of Life - 5 Dimensions

    Time frame: 1-5 days before surgery

    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.

  3. Patient Health Questionnaire

    Time frame: 1-5 days before surgery

    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.

  4. Pain Catastrophizing Scale

    Time frame: 1-5 days before surgery

    Score of PCS questionnaire (Pain Catastrophizing Scale). It consists of 13 items, and each item is scored on a scale of 0-4.

  5. Big Five Inventory-10

    Time frame: 1-5 days before surgery

    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.

  6. Hamilton Depression Rating Scale

    Time frame: 1-5 days before surgery

    Score of HAM-D (Hamilton Depression Rating Scale) examination. It consists of 17 items to evalulate depression, and higher scores indicate more severe depression.

  7. Hamilton Anxiety Rating Scale

    Time frame: 1-5 days before surgery

    Score of HAM-A (Hamilton Anxiety Rating Scale) examination. It consists of 14 items to evalulate anxiety, and higher scores indicate more severe anxiety.

  8. PainDETECT

    Time frame: 1-5 days before surgery

    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.

  9. Temporal pain summation

    Time frame: 1-5 days before surgery

    Compare the pain after a single stimulation with the pain after 10 repeated stimulations.

  10. Pressure pain threshold

    Time frame: 1-5 days before surgery

    The lowest pressure at which the participant perceives pain. It is measured by pressure algometry.

  11. Pressure pain tolerance

    Time frame: 1-5 days before surgery

    The highest pressure when the participant perceived untolerable pain. It is measured by pressure algometry.

  12. Frontal Electroencephalogram

    Time frame: perioperative period

    Band power and connectivity in electroencephalogram

  13. Analgesia Nociception Index (ANI)

    Time frame: perioperative period

    Analgesia Nociception Index (ANI) from ANI monitoring

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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