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Comparison of the effects of Ephedrine and Ketamine with Placebo on onset time of Atracurium in patients under general anesthesia

Protocol summary

Study aim
Comparison of the effects of Ephedrine and Ketamine with Placebo on the onset time of Atracurium in patients undergoing general anesthesia
Design
141 patients, aged 15 _ 65 years, undergoing elective surgery were include in this clinical trial study. By using statistical software, patients were randomly divided into three groups with 47 patients each. All patients gave their informed conset and the study protocol was approved by the local ethics comittee. This study includes two parallel case groups and one control group . This is a phase 2_3 clinical trial in a double-blind, randomized fashion.
Settings and conduct
After obtaining informed conset, 141 patients aged 15-65 years old, with the ASA classification 1 or 2, scheduled for elective surgery at Shariati hospital, were enrolled in the study. All of the patients were premedicated with midazolam, fentanyl and propofol. patients in Ketamine group received 0.5 mg/kg Ketamine, patients in Ephedrine group received 0.05 mg/kg Ephedrine, and as placebo, 5cc of Normal Saline was given to patients in the control group. 30 seconds after the first injection, 0.5 mg/kg Atracurium was administered to all the patients. 2 minutes after the administration of fentanyl, Neuromuscular blockade monitoring on the arm was initiated.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with the ASA classes 1 or 2 Patients undergoing elective surgery Exclusion criteria : Patients with BMI less than 16.5 or above 35 Patients with mallampati score 3 or more History of HTN or IHD within one year prior to the surgery
Intervention groups
Patients are randomly divided into three groups: patients receiving Ephedrine, patients receiving Ketamine, and the control group that are receiving Normal Saline as placebo. The onset time of Atracurium will be compared between the groups.
Main outcome variables
The onset time of Atracurium in seconds

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190721044285N1
Registration date: 2019-07-31, 1398/05/09
Registration timing: prospective

Last update: 2019-07-31, 1398/05/09
Update count: 0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Mohammad Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 4646
Email address
mhd.ghasemi371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Ephedrine and Ketamine with Placebo on onset time of Atracurium in patients under general anesthesia
Public title
Effect of Ephedrine and Ketamine on onset time of Atracurium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA score 1 or 2 Patients undergoing elective surgery 8 hours fasting at least
Exclusion criteria:
Patients with BMI between 16.5 to 35 Liver or kidney disease Patients with mallampati test 3 or more Patients with HTN or IHD in one year ago
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 141
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided with Random Allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients have informed consent for intervention, but they dont know which group they are in. The outcome evaluator is also unaware of the patient group The data analyst will analyse the data in 3 groups that the drug used by each group is unknown
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Shariati hospital, North Amir Abad Ave
City
Tehran
Province
Tehran
Postal code
3415719451
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.108

Health conditions studied

1

Description of health condition studied
Intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
Shorten the onset time of the effect of Atracurium
Timepoint
2 minutes after the administration of fentanyl until 2 response in Train Of Four at 10 seconds intervals
Method of measurement
Nerve Stimulator ( train of four )

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: In this group, each patient is given 0.05 mg/kg Ephedrine intravenous before injection of Atracurium
Category
Prevention

2

Description
Intervention group: In this group, each patient is given 0.5 mg/kg Ketamine intravenous before injection of Atracurium
Category
Prevention

3

Description
Control group: In this group each patient is given 5cc Normal Saline intravenous as a placebo before injection of Atracurium
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohammad Ghasemi
Street address
Shariati hospital , North Amir Abad
City
Tehran
Province
Tehran
Postal code
3415719451
Phone
+98 28 3333 4646
Email
mhd.ghasemi371@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokofeh Nikfar
Street address
TUMS, porsina Ave, 16 Azar Blvd
City
Tehran
Province
Tehran
Postal code
3415719451
Phone
+98 28 3333 4646
Email
mhd.ghasemi371@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ghasemi
Position
Medico
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shariati hospital, North Amir Abad Ave
City
Tehran
Province
Tehran
Postal code
3415719451
Phone
+98 28 3333 4646
Email
mhd.ghasemi371@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ghasemi
Position
Medico
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shariati hospital, North Amir Abad Ave
City
Tehran
Province
Tehran
Postal code
3415719451
Phone
+98 28 3333 4646
Email
mhd.ghasemi371@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ghasemi
Position
Medico
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shariati hospital, North Amir Abad Ave
City
Tehran
Province
Tehran
Postal code
3415719451
Phone
+98 28 3333 4646
Email
mhd.ghasemi371@gmail.com

Sharing plan

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
The Analysis of the main outcome data will be published
When the data will become available and for how long
6 months later
To whom data/document is available
Reseachers
Under which criteria data/document could be used
__
From where data/document is obtainable
Mohammad ghasemi Tel : 09127852900
What processes are involved for a request to access data/document
___
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