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

A randomized controlled trial of the effect of remimazolam on postoperative QT interval in gynecologic laparotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051220068
Enrollment
120
Registered
2022-07-26
Start date
2022-09-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for gynecologic laparotomy

Interventions

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 atte

Sponsors

Hori Kotaro
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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 ( 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

Design outcomes

Primary

MeasureTime frame
Heart-rate corrected QT (QTc) interval after tracheal extubation

Secondary

MeasureTime frame
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

Contacts

Public ContactKotaro Hori

Osaka Metropolitan University Graduate School of Medicine

k.hori@omu.ac.jp+81-666452186

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026