Protocol summary

Study aim
Investigating the effect of changes in heart rate and blood pressure in the use of Dosecam Ketamine with Dexmedetomidine and Dosecam Ketamine with Propofol in cataract surgery by phacoemulsification method
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial with a sample size of 128 patients was designed in a phase 3 trial.
Settings and conduct
This is a randomized double-blind clinical trial that will be conducted on 60 patients who are candidates for cataract surgery in Faiz Hospital, Isfahan. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients are randomly allocated into groups, in each group the desired intervention is applied and the patient's clinical symptoms are recorded. The person who applies the intervention is different from the researcher who evaluates the symptoms and also They do not know the type of intervention. Even though the patients are included in the study, they are not aware of the type of intervention applied and therefore they are all blind.
Participants/Inclusion and exclusion criteria
Patients aged 18 years and above r who undergo cataract surgery for the first time by phacoemulsification method and are in ASA class 1 to 3. Non-entry criteria: Patients with obstructive sleep apnea, diabetes, mental illnesses, autoimmune diseases, nystagmus, leukemia, epilepsy, patients treated with psychiatric drugs, deafness and drug allergy and use of painkillers in the past week, BMI index greater than 35 .
Intervention groups
People who take the first combination of ketamine with dexmedetomidine in group a and people who take the second combination of medicine with dexmedetomidine and group b are placed in the group of the second combination of medicine and ketamine with propofol.
Main outcome variables
Heart rate ;blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N43
Registration date: 2022-09-07, 1401/06/16
Registration timing: registered_while_recruiting

Last update: 2022-09-07, 1401/06/16
Update count: 0
Registration date
2022-09-07, 1401/06/16
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
2022-08-23, 1401/06/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of changes in heart rate and blood pressure in the use of Dosecam Ketamine with Dexmedetomidine and Dosecam Ketamine with Propofol in cataract surgery under local anesthesia by phacoemulsification method.
Public title
Comparative study of changes in heart rate and blood pressure in the use of Dosecam Ketamine with Dexmedetomidine and Dosecam Ketamine with Propofol in cataract surgery under local anesthesia by phacoemulsification method.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 years and older For the first time, they undergo cataract surgery using phacoemulsification be in ASA class 1 to 3
Exclusion criteria:
Patients with obstructive sleep apnea diabetes , mental illnesses , Autoimmune diseases Nystagmus Leukemia , epilepsy Patients treated with psychiatric drugs , Deafness Drug allergy Use of painkillers in the past week BMI index greater than 35
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are collected by easy and continuous sampling method. . Then the samples were randomly divided into two groups by computer randomization using relevant software. Sampling continues until the samples reach the set limit. Sampling is done using unique codes and they are placed in 2 groups a or b. People who take the first combination of ketamine with dexmedetomidine in group a and people who take the second combination of medicine with dexmedetomidine and group b are placed in the group of the second combination of medicine and ketamine with propofol.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The method of blinding is that patients are unaware of the type of drug they are given and drugs provided in similar syringes and coded for those by the researcher and given to the study expert to inject. and the hemodynamic changes are monitored and recorded, so the attending, the clinical caregiver, the examiner, and the data analyzer will not understand the type of medication and the investigator deciphers the codes after data analysis.
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
2022-05-08, 1401/02/18
Ethics committee reference number
IR.MUI.MED.REC.1401.047

Health conditions studied

1

Description of health condition studied
heart rate
ICD-10 code
R00.1
ICD-10 code description
Bradycardia, unspecified

2

Description of health condition studied
Hypotension
ICD-10 code
I95
ICD-10 code description
Hypotension

Primary outcomes

1

Description
heart rate
Timepoint
Before injecting anesthetic, one minute after injecting anesthetic, five minutes after injecting anesthetic, every ten minutes during surgery and every ten minutes during recovery until discharge.
Method of measurement
NIBP Noninvasive Blood Pressure measurement by an anesthesiologist

2

Description
bloodpressure
Timepoint
Before injecting anesthetic, one minute after injecting anesthetic, five minutes after injecting anesthetic, every ten minutes during surgery and every ten minutes during recovery until discharge.
Method of measurement
NIBP Noninvasive Blood Pressure measurement by an anesthesiologist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: First, informed consent is obtained from the patients. After placing the patients on the bed of the operating room, standard monitoring including blood pressure gauges and basic vital signs are recorded. Ketamine is injected intravenously with dexmedetomidine to the patient, the desired variables are recorded at the desired times.
Category
Treatment - Drugs

2

Description
Intervention group: First, informed consent is obtained from the patients. After placing the patients on the bed of the operating room, standard monitoring including blood pressure gauges and basic vital signs are recorded. Ketamine is injected intravenously with dexmedetomidine to the patient, the desired variables are recorded at the desired times.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faiz Hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Modares St, Qods Sq
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3445 2031
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
Dr. Mansour Siavash Dastjardi
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
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjirib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3212 3543
Fax
+98 31 3669 1510
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 Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjirib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3212 3543
Fax
+98 31 3669 1510
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
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjirib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3212 3543
Fax
+98 31 3669 1510
Email
behzad_nazem@med.mui.ac.ir

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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