The Effect of Remimazolam on Opioid Induced Hyperalgesia

Wonkwang University Hospital

Status: Completed

Conditions: Hyperalgesia, Mechanical

Treatments: Drug: Remimazolam; Drug: Desflurane; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05866315

Wonkwang UH13

Details and patient eligibility

About

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).

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups

Group DLR

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Desflurane

Group DHR

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Desflurane

Group RHR

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Remimazolam