A clinical trial of the effect of remimazolam on postoperative ECG in gynecologic laparotomy

JRCT ID: jRCT1051220068

Registered date:26/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled for gynecologic laparotomy
• Date of first enrollment: 06/09/2022
• Target sample size: 120
• Study type: Interventional

Intervention(s)

In remimazolam group, remiazolam administration is initiated at 12 mg/kg/h until patients lose their consciousness, and then is decreased at 1 mg/kg/h. The maintenace dose is at the discretion of attending anesthesiologists by using BIS (bispectral index).
In sevoflurane group, anesthesia induction is performed with 2 mg/kg propofol bolus. The maintenace dose of sevoflurane is at the discretion of attending anesthesiologists by using BIS.

Outcome(s)

• Primary Outcome: Heart-rate corrected QT (QTc) interval after tracheal extubation

Secondary Outcome

1) Correlation between plasma concentration of remimazolam and QTc
2) Correlation between plasma concentration of ropivacaine and QTc
3) QTc interval during induction of anesthesia
4) Hourly QTc inteval from the beggining to the end of surgery
5) QTc interval at postoperative day 1
6) Incidecne of perioperative fatal arrhythmia through medical record review

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Patients scheduled for genecologic laparatomy
under general anesthesia
2) Patients aged 20 or older
3) Patients classified as ASA-PS 1 or 2 (American Society of Anesthesiologists-Physical Status)
4) Patients who fully understand the study after sufficient explanations and provide the written volun
tary consent

Exclude criteria

1) Patients who have contraindication or allergy to sevoflurane or remimazolam
2) Patients who have abnormal QT interval in preoperative ECG
3) Patients who do not have sinus rhythm in preoperative ECG
4) Patients who take antipsychotics, antiarrhythmics, or beta-blockers
5) Patients who have hypokalemia (< 3.5 mEq/L) or hyperkalemia (> 5.5 mEq/L) in preoperative labor
atory data
6) Patients whose BMI are 35 or greater
7) Patient who are considered ineligible for enrolling the study by a principal- or co-investigator

Related Information

• Primary Sponsor: Hori Kotaro
• Secondary Sponsor: Mori Takashi