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Clinical Trials/jRCT1051220068
jRCT1051220068RecruitingNot Applicable

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

Not provided0 sites120 target enrollmentStarted: September 6, 2022Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
20age old over to No limit (—)
Sex
Female

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

-

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

Secondary Outcomes

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

Investigators

Sponsor
Not provided

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