Clinical trial NCT05866315: The Effect of Remimazolam on Opioid Induced Hyperalgesia
Official title: The Effect of Remimazolam on Remifentanil-induced Hyperalgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperalgesia, Mechanical
Keywords: remifentanil
remimazolam
opioid-induced hyperalgesia
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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).

Primary outcomes:
measure: The mechanical hyperalgesia threshold
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: Time to first postoperative analgesic requirement
timeFrame: Within 1 hour after surgery
measure: Injected PCA volume containing morphine for 24 h after surgery
timeFrame: 24 hours after surgery
measure: Pain intensity
timeFrame: 1 hour after surgery
measure: Pain intensity
timeFrame: 6 hours after surgery
measure: Pain intensity
timeFrame: 12 hours after surgery
measure: Pain intensity
timeFrame: 24 hours after surgery
measure: Area of hyperalgesia around surgical incision
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwag UH
state: Jeollabukdo
city: Iksan
country: Korea, Republic of
facility: Wonkwang University hospital
Study officials:
affiliation: Wonkwang University Hospital
name: Cheol Lee, M.D.,Ph.D.
role: STUDY_DIRECTOR
References: