Comparison of the effectiveness of low-dose Ephedrine and Ketamine injections on rapid sequence intubation using Priming Dose of Cis-Atracurium in patients under general anesthesia
Comparison of the effect of Ephedrine and Ketamine injection on rapid chip piping with Priming dose method
Design
A clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 128 patients. A randomization table is used for randomization
Settings and conduct
This study is a double-blind randomized controlled clinical trial in which the target population will be candidates for elective surgery under general anesthesia in Al-Zahra Hospital in Isfahan. Patients are divided into 4 groups by simple random allocation. After being placed on the operating table and connected to the monitor, each group was injected with one of the drug interventions before the induction of anesthesia. The patient's vital signs and hemodynamic status are monitored and recorded before, during, and after surgery. The intervention groups are coded so the injector, clinical caregiver, surgeon, and patient are unaware of the injected intervention and are blind
Participants/Inclusion and exclusion criteria
All patients with general anesthesia candidates aged 18 to 65 years and with class I ASA and II can enter this study if they have no history of hypersensitivity, either moderate to severe.
Intervention groups
Intervention group E: 70 micrograms of Ephedrine per kilogram of body weight, intervention group K: 0.5 mg of Ketamine per kilogram of body weight, intervention group E + K: 70 micrograms of Ephedrine and 0.5 mg of Ketamine and group N: Normal saline
is injected into patients before induction of anesthesia.
Main outcome variables
Mouth opening; Jaw condition; , The condition of the vocal cords; Diaphragm position
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N24
Registration date:2020-09-19, 1399/06/29
Registration timing:registered_while_recruiting
Last update:2020-09-19, 1399/06/29
Update count:0
Registration date
2020-09-19, 1399/06/29
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of low-dose Ephedrine and Ketamine injections on rapid sequence intubation using Priming Dose of Cis-Atracurium in patients under general anesthesia
Public title
Effect of Ephedrine and Ketamine on rapid sequence intubation using Priming Dose of Cis-Atracurium
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are candidates for elective surgery under general anesthesia
Age 18 to 65 years
ASA Class I and II Anesthesia
Patient consent to study
Exclusion criteria:
History of moderate to severe allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way so that the names of patients enter the randomization software (https://random-allocation-software.software.informer.com/2.0/) if they have the necessary conditions and according to the time of entry. software Randomly assign numbers to each patient, and based on these numbers, patients enter one of the intervention or control groups so that their number reaches the required number in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Four packs of drugs A, B, C, D are prepared, each of which contains coded syringes of one shape, and for each patient, a syringe is selected from the packs according to their selected group. And is injected into the patient, the prescriber (anesthesiologist), and the person who records the symptoms
Also, patients are unaware of the prescribed drug and therefore both parties are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-08-26, 1398/06/04
Ethics committee reference number
IR.MUI.MED.REC.1398.644
Health conditions studied
1
Description of health condition studied
Rapid sequence intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reaction to laryngoscopy
Timepoint
60 seconds after Cis Atracurium injection
Method of measurement
Cooper Scoring Criterion
2
Description
Position of vocal cords
Timepoint
60 seconds after Cis Atracurium injection
Method of measurement
Cooper Scoring Criterion
3
Description
Diaphragm muscle movement
Timepoint
60 seconds after Cis Atracurium injection
Method of measurement
Cooper Scoring Criterion
4
Description
Opening the patient's mouth
Timepoint
60 seconds after Cis Atracurium injection
Method of measurement
Cooper Scoring Criterion
Secondary outcomes
1
Description
Heart rate
Timepoint
Before induction of anesthesia, after induction of anesthesia, and every 15 minutes until the end of anesthesia
Method of measurement
ECG monitoring
2
Description
Oxygen saturation
Timepoint
Before induction of anesthesia, after induction of anesthesia, and every 15 minutes until the end of anesthesia
Method of measurement
Pulse oximeter
3
Description
Blood Pressure
Timepoint
Before induction of anesthesia, after induction of anesthesia, and every 15 minutes until the end of anesthesia
Method of measurement
Non-invasive blood pressure measurement
4
Description
Drug side effects
Timepoint
From the end of anesthesia to the end of recovery
Method of measurement
Observe and ask the patient
5
Description
Recovery time
Timepoint
From the end of anesthesia to the exit of recovery
Method of measurement
Timer
Intervention groups
1
Description
Intervention group E: each patient is injected with Ephedrine 70 Mcr gr/kg before induction.
Category
Treatment - Drugs
2
Description
Intervention group: K: That each patient is injected with 0.5 mg/kg Ketamine before induction.
Category
Treatment - Drugs
3
Description
Intervention group E + K: each patient is injected with 70 micro grams of Ephedrine and 0.5 mg of Ketamine per kilogram of body weight before induction.
Category
Treatment - Drugs
4
Description
Control group N: Normal saline is injected into the patient before induction.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Alzahra hospital
Full name of responsible person
Behzad Nazem Roaya
Street address
Soffeh Boulevard, Shahid Keshvari Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Esfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pouyan Nadery Afshar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Esfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazem Roaya
Position
Professor assistant of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leyla Rafiei
Position
Nurse Anesthesia
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Esfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
leylarafiei943@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available