The Effect of Remimazolam on Opioid Induced Hyperalgesia

Sponsor

Wonkwang University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05866315

Collaborator

(none)

108

Enrollment

Locations

Arms

1.7

Anticipated Duration (Months)

Patients Per Site

32.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hyperalgesia, Mechanical	Other: Remimazolam, Desflurane	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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. 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. 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.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. 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. 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 (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

The Effect of Remimazolam on Remifentanil-induced Hyperalgesia

Anticipated Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

May 20, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group DLR 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.	Other: Remimazolam, Desflurane Administer remimazolam or desflurane Other Names: Remifentanil
Experimental: Group DHR 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.	Other: Remimazolam, Desflurane Administer remimazolam or desflurane Other Names: Remifentanil
Experimental: Group RHR 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.	Other: Remimazolam, Desflurane Administer remimazolam or desflurane Other Names: Remifentanil

Arm

Intervention/Treatment

Active Comparator: Group DLR

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.

Other: Remimazolam, Desflurane

Administer remimazolam or desflurane

Other Names:

Remifentanil

Experimental: Group DHR

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.

Other: Remimazolam, Desflurane

Administer remimazolam or desflurane

Other Names:

Remifentanil

Experimental: Group RHR

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.

Other: Remimazolam, Desflurane

Administer remimazolam or desflurane

Other Names:

Remifentanil

Outcome Measures

Primary Outcome Measures

The mechanical hyperalgesia threshold [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 Outcome Measures

Time to first postoperative analgesic requirement [Within 1 hour after surgery]
Time to first postoperative analgesic requirement (min)
Injected PCA volume containing morphine for 24 h after surgery [24 hours after surgery]
Injected PCA volume containing morphine for 24 h after surgery (ml)
Pain intensity [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".
Pain intensity [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".
Pain intensity [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".
Pain intensity [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".
Area of hyperalgesia around surgical incision [24 hours after surgery]
Area of hyperalgesia around surgical incision (cm^2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).