Evaluation of hemodynamic changes between isoflurane and sevoflurane anesthesia groups in infants under one year of age
Design
A clinical trial with intervention and control groups, with parallel groups, double-blind, randomized, a sample of 68 patients, creating random numbers using a calculator.
Settings and conduct
All infants who are candidates for limited surgery at Tabriz Children's Hospital will be included in this study. Patients are randomly assigned to intervention and control groups. In this study, the patient (who is an infant) and the anesthesia nurse and one of the anesthesiologists are blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Infants under one year of age are candidates for elective surgery in less than one hour.
Exclusion criteria:
Requires endotracheal intubation for surgery;
Underlying cardiovascular disease.
Intervention groups
Intervention group: 34 infants are placed under anesthesia with 1.5% isoflurane in a mixture of 50% oxygen and 50% N2O, and hemodynamic changes are carefully monitored.
Control group: 34 infants are anesthetized with 2.5% sevoflurane in a mixture of 50% O2 and 50% N2O, and hemodynamic changes are carefully monitored.
Main outcome variables
Systolic and diastolic blood pressure, Heart rate, Saturation of peripheral oxygen, nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100527004041N23
Registration date:2021-07-25, 1400/05/03
Registration timing:prospective
Last update:2021-07-25, 1400/05/03
Update count:0
Registration date
2021-07-25, 1400/05/03
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthesia maintenance with Isoflurane or Sevoflurane with Laryngeal mask during minor surgery in newborns and infants
Public title
Comparison of maintenance anesthesia with isoflurane or sevoflurane in neonates and infants during surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infants under one year of age
candidates for elective surgery less than one hour
Exclusion criteria:
Requires endotracheal intubation for surgery
Underlying cardiovascular disease
Age
From 1 day old to 1 year old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table that includes numbers from 1 to 68. With each refers until the 68th patient, we create a number using the random selection system of the calculator (each number has a chance to happen only once). According to the created number, each patient is in one of the two intervention groups: 1 anesthesia with isoflurane (34 people) and the control group with anesthesia with sevoflurane (34 people). If the random number is odd, the patient places in the intervention group. If the number is even, the patient is allocated into the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 2 anesthesiologists will participate. Anesthesiologist No. 1, who will induce anesthesia in both groups, and be aware of the allocation of each patient (codes and type of anesthesia), will leave the operation room. The anesthesiologist No. 2 and the anesthesia nurse, responsible for collecting information and variables, are unaware of the type of prescription medications. They will fill the checklists during the surgery and in the recovery section. Patients (infants) and their parents are also unaware of the allocation. But the baby's parents are fully aware of the used medications in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.TBZMED.REC.1400.239
Health conditions studied
1
Description of health condition studied
Comparison of hemodynamic changes after anesthesia with sevoflurane and isoflurane.
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Mercury barometer
2
Description
Heart rate
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Counting in each minutes
3
Description
Saturation of peripheral oxygen
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Via the Pulse Oximeter
4
Description
nausea and vomiting
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 34 infants are placed under anesthesia with 1.5% isoflurane in a mixture of 50% oxygen and 50% N2O, and hemodynamic changes are carefully monitored.
Category
Diagnosis
2
Description
Control group: 34 infants are anesthetized with 2.5% sevoflurane in a mixture of 50% O2 and 50% N2O, and hemodynamic changes are carefully monitored.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Mahin Seyedhejazi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , seidhejazie@tbzmed.ac.ir
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.