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NCT Number: NCT05866315

The Effect of Remimazolam on Opioid Induced Hyperalgesia

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).

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonkwag UH, Iksan, Jeollabukdo, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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).

Treatment and study plan

Remimazolam

Drug

Administer remimazolam

Other names: Byfavo

Desflurane

Drug

administer desflurane

Other names: desfuralne

Remifentanil

Drug

administer remifentanil

Other names: Ulitva

Primary outcomes

  1. The mechanical hyperalgesia threshold

    Time frame: 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 outcomes

  1. Time to first postoperative analgesic requirement

    Time frame: Within 1 hour after surgery

    Time to first postoperative analgesic requirement (min)

  2. Injected PCA volume containing morphine for 24 h after surgery

    Time frame: 24 hours after surgery

    Injected PCA volume containing morphine for 24 h after surgery (ml)

  3. Pain intensity

    Time frame: 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".

  4. Pain intensity

    Time frame: 6 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".

  5. Pain intensity

    Time frame: 12 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".

  6. Pain intensity

    Time frame: 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".

  7. Area of hyperalgesia around surgical incision

    Time frame: 24 hours after surgery

    Area of hyperalgesia around surgical incision (cm^2)

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

The Effect of Remimazolam on Remifentanil-induced Hyperalgesia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 19, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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