Protocol summary

Study aim
Comparison of hemodynamic changes caused by induction of anesthesia with Ketamine-Propofol, and Etomidate in patients over 65 years old
Design
A parallel-group, triple-blind, randomized, phase 2 clinical trial on 90 patients. Random allocation software is used for randomization.
Settings and conduct
This is a three-blind randomized clinical trial that will be conducted on 90 patients in Al-Zahra Hospital, Isfahan. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients are randomly assigned into groups, in each group the desired intervention is applied and the clinical symptoms of the patient are recorded. The researcher who records the patient's symptoms, the analysts who collect the data analyzed during the study, and the patients did not know the type of intervention applied in each group, so they were all blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 65 years, candidate for elective surgery under general anesthesia, ASA class I and II, informed consent to participate in the study. Non-Inclusion criteria: history of drug, alcohol, and benzodiazepine use, BMI higher than 30, history of seizures, adrenal insufficiency, high blood pressure
Intervention groups
Intervention group A: Patients in this group first received 2 micrograms/kg of Fentanyl and 2mg of intravenous Midazolam. Then, they receive 0.6 mg/kg Atracurium and 1.5 mg/kg Lidocaine, as well as 0.3 mg/kg Etomidate at a rate of 0.1mg/kg/min to induce anesthesia. Intervention group B: Patients in this group first received 2 micrograms/kg of Fentanyl and 2mg of intravenous Midazolam. Then, they receive 0.6 mg/kg of Atracurium and 1.5 mg/kg of Lidocaine, as well as 1.5 mg/kg of Propofol at a rate of 0.5 cc/s and 0.5 mg/kg of Ketamine at a rate of 0.5 mg/kg/min to induce anesthesia.
Main outcome variables
Blood Pressure; Heart Rate; O2 Sat

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N46
Registration date: 2022-09-24, 1401/07/02
Registration timing: registered_while_recruiting

Last update: 2022-09-24, 1401/07/02
Update count: 0
Registration date
2022-09-24, 1401/07/02
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
2022-09-23, 1401/07/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes caused by induction of anesthesia with Ketamine-Propofol, and Etomidate in patients over 65 years old
Public title
Comparison of hemodynamic changes caused by induction of anesthesia with Ketamine-Propofol and Etomidate
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 65 years old Candidate for elective surgery under general anesthesia Anesthesia class I and II according to ASA criteria Informed consent to enter the study
Exclusion criteria:
History of drug, alcohol and Benzodiazepine use BMI (Body Mass Index)>30 History of seizures Adrenal gland failure High Blood Pressure Candidate for Craniotomy surgery
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple blind clinical trial; In this way, the patient is included in the study but does not know the type of intervention applied and is blind, the researcher who records the patient's symptoms is also different from the person who injects the drug and without knowing the type of drug only records the patient's symptoms during the study and therefore is kept blind. The analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.MUI.MED.REC.1401.162

Health conditions studied

1

Description of health condition studied
Hemodynamic changes in anesthesia induction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood Pressure
Timepoint
before induction of anesthesia, after induction of anesthesia, before laryngoscopy, 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Sphygmomanometer

2

Description
Heart Rate
Timepoint
before induction of anesthesia, after induction of anesthesia, before laryngoscopy, 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Electrocardiogram

3

Description
O2 Saturation
Timepoint
before induction of anesthesia, after induction of anesthesia, before laryngoscopy, 1, 3, 5 and 10 minutes after laryngoscopy
Method of measurement
Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Patients in this group received 2 Micrograms/kg of fentanyl manufactured by Aburihan Pharmaceutical Company and 2mg of intravenous Midazolam manufactured by Elixir Pharmaceutical Company after connecting the monitoring devices and preparing vital sign recording devices. Then 0.6mg/kg Atracurium was manufactured by Caspian Pharmaceutical Company and 1.5mg/kg Lidocaine was manufactured by Caspian Pharmaceutical Company as well as 0.3mg/kg Etomidate was manufactured by Ayman Sahar Pharmaceutical Company at a rate of 0.1mg/kg/min for induction of anesthesia and after About three minutes of ventilation with a face mask, tracheal intubation is performed, and the patient's symptoms are measured and recorded.
Category
Diagnosis

2

Description
Intervention group B: Patients in this group received 2 Micrograms/kg of fentanyl manufactured by Aburihan Pharmaceutical Company and 2mg of intravenous Midazolam manufactured by Elixir Pharmaceutical Company after connecting the monitoring and preparing vital sign recording devices. Then 0.6mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company and 1.5mg/kg of Lidocaine manufactured by Caspian Pharmaceutical Company and also 1.5mg/kg of Propofol produced by Darman Yab Daro Company at a speed of 0.5cc/s and 0.5mg/kg of Ketamine produced by Darman Yab Daro Company. are given at a rate of 0.5 mg/kg/min to induce anesthesia, and after about three minutes of ventilation with a face mask, tracheal intubation is performed and the patient's symptoms are measured and recorded.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazem Roaya
Street address
Alzahra hospital, Soffe blvd.
City
Isfahan
Province
Isfehan
Postal code
81746 75731
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
Hezar Jarib
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
Marzieh Soheyli Pur
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
Msoheili8896@gmail.com

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
Hezar Jarib
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 Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
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
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