An interventional study of Remimazolam and Desflurane in Hyperalgesia, Mechanical, sponsored by Wonkwang University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Wonkwang University Hospital · Not applicable, Interventional, and Prevention
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.
166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.
This study's enrollment of 108 is above the median of 50 across 142 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Wonkwang University Hospital is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Desflurane · Drug: Remifentanil
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.
Drug: Desflurane · Drug: 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.
Drug: Remimazolam · Drug: Remifentanil
Administer remimazolam
Also known as: Byfavo
administer desflurane
Also known as: desfuralne
administer remifentanil
Also known as: Ulitva
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).
Time frame: at 24 hours after surgery
Time to first postoperative analgesic requirement
Time to first postoperative analgesic requirement (min)
Time frame: Within 1 hour after surgery
Injected PCA volume containing morphine for 24 h after surgery
Injected PCA volume containing morphine for 24 h after surgery (ml)
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 24 hours after surgery
Area of hyperalgesia around surgical incision
Area of hyperalgesia around surgical incision (cm\^2)
Time frame: 24 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Sep 2023, 3 months.
Of 27 non-industry interventional studies with no phase under Hyperalgesia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's 3 months is below that.
Counting every sponsor, half of 27 studies reached it within 11 months; a quarter within 4 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remimazolam
Wonkwang University Hospital