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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFA group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption in postoperative 24hrs | Total opioid dose administered to the patient. | 24 hours after surgery |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Seoul | South Korea | ||||
| Gangnam Severance Hsopital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38838608 | Derived | Bae MI, Oh J, Lee HS, Park S, Kwon IG, Song Y. Influence of psychological factors and pain sensitivity on the efficacy of opioid-free anesthesia: A randomized clinical trial. Gen Hosp Psychiatry. 2024 Jul-Aug;89:84-92. doi: 10.1016/j.genhosppsych.2024.04.001. Epub 2024 Apr 4. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Patients don't know which group they belong to.
|
| 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. |
|
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 |
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 |
| Seoul |
| South Korea |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |