Remimazolam
DrugAdminister remimazolam
Other names: Byfavo
NCT Number: NCT05866315
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:
* [The mechanical hyperalgesia threshold] * [Area of hyperalgesia around the surgical incision 24 h after surgery (cm^2)]
In three groups: Group RHR (Remimazolam- High-dose Remifentanil), Group DHR (Desflurane-low-dose Remifentanil) or Group DLR (Control).
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Wonkwag UH, Iksan, Jeollabukdo, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Administer remimazolam
Other names: Byfavo
administer desflurane
Other names: desfuralne
administer remifentanil
Other names: Ulitva
Time frame: at 24 hours after surgery
The mechanical hyperalgesia threshold (g/mm^2) (preoperative) and 2 cm from the single port incision site (postoperative) at four points (horizontally and perpendicularly).
Time frame: Within 1 hour after surgery
Time to first postoperative analgesic requirement (min)
Time frame: 24 hours after surgery
Injected PCA volume containing morphine for 24 h after surgery (ml)
Time frame: 1 hour after surgery
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Time frame: 6 hours after surgery
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Time frame: 12 hours after surgery
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Time frame: 24 hours after surgery
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Time frame: 24 hours after surgery
Area of hyperalgesia around surgical incision (cm^2)
Wonkwang University Hospital
Other
The Effect of Remimazolam on Remifentanil-induced Hyperalgesia
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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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