NCT05866315

The Effect of Remimazolam on Opioid Induced Hyperalgesia

The Effect of Remimazolam on Remifentanil-induced Hyperalgesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Wonkwang University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperalgesia, Mechanical

Interventions

Type	Name	Description
DRUG	Remimazolam	Administer remimazolam
DRUG	Desflurane	administer desflurane
DRUG	Remifentanil	administer remifentanil

Timeline

• Start date: 2023-05-19
• Primary completion: 2023-09-06
• Completion: 2023-09-15
• First posted: 2023-05-19
• Last updated: 2023-10-06

Locations

2 sites across 1 country: South Korea