The Effect of Remimazolam on Opioid Induced Hyperalgesia
- Conditions
- Hyperalgesia, Mechanical
- Interventions
- Registration Number
- NCT05866315
- Lead Sponsor
- Wonkwang University Hospital
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group DHR Desflurane 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 DHR 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. Group DLR Desflurane 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 DLR Remifentanil 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 RHR Remimazolam 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 RHR 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.
- Primary Outcome Measures
Name Time Method The mechanical hyperalgesia threshold 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).
- Secondary Outcome Measures
Name Time Method Area of hyperalgesia around surgical incision 24 hours after surgery Area of hyperalgesia around surgical incision (cm\^2)
Time to first postoperative analgesic requirement Within 1 hour after surgery Time to first postoperative analgesic requirement (min)
Pain intensity 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".
Injected PCA volume containing morphine for 24 h after surgery 24 hours after surgery Injected PCA volume containing morphine for 24 h after surgery (ml)
Trial Locations
- Locations (2)
Wonkwag UH
🇰🇷Iksan, Jeollabukdo, Korea, Republic of
Wonkwang University hospital
🇰🇷Iksan, Korea, Republic of