Hyperalgesia, MechanicalNCT05866315
The Effect of Remimazolam on Opioid Induced Hyperalgesia
A study testing Remimazolam, Desflurane and Remifentanil in people with Hyperalgesia, Mechanical, run by Wonkwang University Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hyperalgesia, Mechanical
- What is being tested?
- Remimazolam, Desflurane and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 19 May 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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).
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Wonkwag UH
Iksan, Jeollabukdo, 54538
Wonkwang University hospital
Iksan, 54538
About this study
Official title: The Effect of Remimazolam on Remifentanil-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).
Read the 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.
- Conditions
- Hyperalgesia, Mechanical
- Being tested
- Remimazolam, Desflurane, Remifentanil
- Keywords
- remifentanil, remimazolam, opioid-induced hyperalgesia
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Byfavo
Administer remimazolam
DesfluraneDrug
Also called desfuralne
administer desflurane
RemifentanilDrug
Also called Ulitva
administer remifentanil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Remimazolam; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 24 hours after surgery
Secondary outcomes (7)
Time to first postoperative analgesic requirement
Time to first postoperative analgesic requirement (min)
Measured: Within 1 hour after surgery
Injected PCA volume containing morphine for 24 h after surgery
Injected PCA volume containing morphine for 24 h after surgery (ml)
Measured: 24 hours after surgery
Pain intensity
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Measured: 1 hour after surgery
Pain intensity
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Measured: 6 hours after surgery
Pain intensity
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Measured: 12 hours after surgery
Pain intensity
The Visual analogue scales (VAS)-100 is a line with words describing the extremes of pain from "no pain" to "worst imaginable pain".
Measured: 24 hours after surgery
Area of hyperalgesia around surgical incision
Area of hyperalgesia around surgical incision (cm^2)
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start19 May 2023
- Primary completion6 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperalgesia, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D.,Ph.D., Study director, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866315
- Sponsor's protocol ID
- Wonkwang UH13
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remimazolam on Remifentanil-induced Hyperalgesia
- ClinicalTrials.gov ID
- NCT05866315
- Acronym / sponsor ID
- Wonkwang UH13
- Conditions
- Hyperalgesia, Mechanical
- Keywords
- remifentanil, remimazolam, opioid-induced hyperalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group DLR | Active comparator | Drug: Desflurane, Drug: RemifentanilAdminister 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. |
| Group DHR | Experimental | Drug: Desflurane, Drug: RemifentanilAdminister 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. |
| Group RHR | Experimental | Drug: Remimazolam, Drug: RemifentanilAdminister remimazolam at a dose of 6 mg/kg/h initially, followed by 1 mg/kg/h, and remifentanil at 0.3 µg/kg/min. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAlso: ByfavoAdminister remimazolam | Drug | Group RHR |
| DesfluraneAlso: desfuralneadminister desflurane | Drug | Group DHR, Group DLR |
| RemifentanilAlso: Ulitvaadminister remifentanil | Drug | Group DHR, Group DLR, Group RHR |
Primary outcome
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).
7 secondary outcomes
Time to first postoperative analgesic requirement
Time frame: Within 1 hour after surgery
Injected PCA volume containing morphine for 24 h after surgery
Time frame: 24 hours after surgery
Pain intensity
Time frame: 1 hour after surgery
Pain intensity
Time frame: 6 hours after surgery
Pain intensity
Time frame: 12 hours after surgery
Pain intensity
Time frame: 24 hours after surgery
Area of hyperalgesia around surgical incision
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol Lee, M.D.,Ph.D. study director
Wonkwang University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam, Desflurane and Remifentanil in people with Hyperalgesia, Mechanical, run by Wonkwang University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mechanical hyperalgesia threshold (time frame: at 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.