The Effect of Remimazolam on Opioid Induced Hyperalgesia

NCT05866315 | Completed DMC

• 1 other identifier: Wonkwang UH13
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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).

Conditions

Hyperalgesia, Mechanical

Keywords

remifentanil; remimazolam; opioid-induced hyperalgesia

Outcome Measures

Primary Outcomes (1)

• The mechanical hyperalgesia threshold

  The mechanical hyperalgesia threshold (g/mm\^2) (preoperative) and 2 cm from the single port incision site (postoperative) at four points (horizontally and perpendicularly).

  at 24 hours after surgery

Secondary Outcomes (7)

• Time to first postoperative analgesic requirement

  Within 1 hour after surgery

• Injected PCA volume containing morphine for 24 h after surgery

  24 hours after surgery

• Pain intensity

  1 hour after surgery

• Pain intensity

  6 hours after surgery

• Pain intensity

  12 hours after surgery

Study Arms (3)

Group DLR

ACTIVE COMPARATOR

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.

Drug: Desflurane; Drug: Remifentanil

Group DHR

EXPERIMENTAL

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.

Drug: Desflurane; Drug: Remifentanil

Group RHR

EXPERIMENTAL

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.

Drug: Remimazolam; Drug: Remifentanil

Interventions

Remimazolam DRUG

Administer remimazolam

Also known as: Byfavo

Group RHR

Desflurane DRUG

administer desflurane

Also known as: desfuralne

Group DHR; Group DLR

Remifentanil DRUG

administer remifentanil

Also known as: Ulitva

Group DHR; Group DLR; Group RHR

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (2)

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

Location

Wonkwang University hospital

Iksan, 54538, South Korea

Location

MeSH Terms

Conditions

Hyperalgesia

Interventions

remimazolam; Desflurane; Remifentanil

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cheol Lee, M.D.,Ph.D.

  Wonkwang University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 19, 2023
• Study Start: May 19, 2023
• Primary Completion: September 6, 2023
• Study Completion: September 15, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)