Trial Outcomes & Findings for Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants (NCT NCT01819064)

Last Updated: 2023-04-06

Results Overview

incidence of bradycardia or other arrhythmias

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

five minutes

Results posted on

2023-04-06

Participant milestones
Measure	Children Weighing Less Than 15Kg This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure and weigh less than 15Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia. Atropine: IV dose at 5 mcg/kg
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants

Baseline characteristics by cohort
Measure	Children Less Than 15Kg. n=60 Participants This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure, and weighed less than 15Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.
Age, Categorical <=18 years	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.5 months n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants
weight	8.1 kilograms n=5 Participants

Timeframe: five minutes

Population: There was no restriction on enrollment so long as the child was \<15 kg.

incidence of bradycardia or other arrhythmias

Outcome measures
Measure	Children Less Than 5Kg. n=9 Participants This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure, and weighed less than 5Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.	Children Weighing 5Kg to 15Kg n=51 Participants This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure, and weighed between 5Kg and 15Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.
Incidence of Bradycardia	0 participants	0 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Children Less Than 15Kg. n=60 participants at risk This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure and weigh less than 5Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia. Atropine: IV dose at 5 mcg/kg
Cardiac disorders asystole	0.00% 0/60 • 1 day until the child is discharged from hospital on the day anesthesia was provided
Cardiac disorders Bradycardia	0.00% 0/60 • 1 day until the child is discharged from hospital on the day anesthesia was provided

Other adverse events
Measure	Children Less Than 15Kg. n=60 participants at risk This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure and weigh less than 5Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia. Atropine: IV dose at 5 mcg/kg
Cardiac disorders arrhythmias	0.00% 0/60 • 1 day until the child is discharged from hospital on the day anesthesia was provided

Women and Children's Hospital of Buffalo, State University of New York at Buffalo

Phone: 7168787701