Hyperalgesia, Mechanical
Conditions
Keywords
remifentanil, remimazolam, opioid-induced hyperalgesia
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.
Interventions
DRUGRemimazolam
Administer remimazolam
DRUGDesflurane
administer desflurane
DRUGRemifentanil
administer remifentanil
Sponsors
Wonkwang University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
1. Group RHR (Remimazolam- High doses of 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. 2. Group DHR (Desflurane-High doses of 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. 3. Group DLR (Desflurane-Low-dose of 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria will include as follows; ASA(American Society of Anesthesiologists)physical status 1-2 patients, Age with 20-65 years, and Single port-laparoscopically assisted urologic surgery. 2.
Exclusion criteria
will include as follows; a known allergy to remimazolam or remifentanil, a history of drug or alcohol abuse, psychiatric disorders, acute cardiovascular disorders, or unstable hypertension, and other respiratory or neuromuscular pathology, treated with opioid-containing any analgesic drug within 24 h before surgery and contraindications to the self-administration of opioids (i.e., were unable to understand the PCA device).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first postoperative analgesic requirement | Within 1 hour after surgery | Time to first postoperative analgesic requirement (min) |
| 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) |
| Pain intensity | 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. |
| Area of hyperalgesia around surgical incision | 24 hours after surgery | Area of hyperalgesia around surgical incision (cm\^2) |
Countries
South Korea
Outcome results
None listed