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The goal of this prospective, randomized, controlled study is to investigate the effect of remimazolam on opioid-induced hyperalgesia (OIH) in patients undergoing single port-laparoscopically assisted urologic surgery.
The main question[s] it aims to answer are:
In three groups: Group RHR (Remimazolam- High-dose Remifentanil), Group DHR (Desflurane-low-dose Remifentanil) or Group DLR (Control).
Ninety-three (n = 31 per group) American Society of Anesthesiologists I-II patients (age 20-65 years) will be scheduled for single port-laparoscopically assisted urologic surgery.
Group RHR (Remimazolam-Remifentanil): Administer remimazolam at a dose of 6 mg/kg/h initially, followed by 1 mg/kg/h, and remifentanil at 0.3 µg/kg/min.
Group DHR (Desflurane-Remifentanil): Administer desflurane at 1 minimum alveolar concentration (MAC), adjusting the dose by 1 vol% titration to maintain MAP and BIS levels, and remifentanil at 0.3 µg/kg/min.
Group DLR (Control): Administer desflurane at 1 MAC, adjust the dose by 1 vol% titration to maintain mean arterial pressure (MAP) and bispectral index (BIS) levels, and remifentanil at 0.3 µg/kg/min.
Mechanical hyperalgesia threshold, Time to first postoperative analgesic requirement (min), Injected PCA volume containing morphine for 12 h after surgery (ml), Pain intensity: VAS 1 h after surgery, VAS 6 h after surgery, VAS 12 h after surgery VAS 24 h after surgery. Area of hyperalgesia around the surgical incision 24 h after surgery (cm^2) will be checked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group DLR | Active Comparator | Administer desflurane at 1 MAC, adjust the dose by 1 vol% titration to maintain MAP and BIS levels, and remifentanil at 0.025 µg/kg/min. |
|
| Group DHR | Experimental | Administer desflurane at 1 MAC, adjusting the dose by 1 vol% titration to maintain MAP and BIS levels, and remifentanil at 0.3 µg/kg/min. |
|
| Group RHR | Experimental | Administer remimazolam at a dose of 6 mg/kg/h initially, followed by 1 mg/kg/h, and remifentanil at 0.3 µg/kg/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Administer remimazolam |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The mechanical hyperalgesia threshold | The mechanical hyperalgesia threshold (g/mm^2) (preoperative) and 2 cm from the single port incision site (postoperative) at four points (horizontally and perpendicularly). | at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first postoperative analgesic requirement | Time to first postoperative analgesic requirement (min) | Within 1 hour after surgery |
| Injected PCA volume containing morphine for 24 h after surgery |
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| Name | Affiliation | Role |
|---|---|---|
| Cheol Lee, M.D.,Ph.D. | Wonkwang University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwag UH | Iksan | Jeollabukdo | 54538 | South Korea | ||
| Wonkwang University hospital |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D000077335 | Desflurane |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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A trained anesthesiologist not involved in general anesthesia assessed clinically relevant and mechanically evoked pain using the Von-Frey filaments and secondary outcomes after surgery.
| Desflurane | Drug | administer desflurane |
|
|
| Remifentanil | Drug | administer remifentanil |
|
|
Injected PCA volume containing morphine for 24 h after surgery (ml)
| 24 hours after surgery |
| Pain intensity | The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain". | 1 hour after surgery |
| Pain intensity | The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain". | 6 hours after surgery |
| Pain intensity | The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain". | 12 hours after surgery |
| Pain intensity | The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain". | 24 hours after surgery |
| Area of hyperalgesia around surgical incision | Area of hyperalgesia around surgical incision (cm^2) | 24 hours after surgery |
| Iksan |
| 54538 |
| South Korea |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |