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Comparison of cardiovascular response to sedation with dexmedetomidine, midazolam and etomidatein phacoemulsification under local anesthesia

Protocol summary

Study aim
Selecting the best drug in terms of maximum efficacy in sedation and minimum rate of complications during and after surgery among the drugs studied.
Design
Clinical trials in two community-based and pragmatic groups with parallel groups, a total volume of 90,double blinded, and randomized
Settings and conduct
The use of three different drugs with specific doses in three groups and comparing their effect on the sedation level in cataract surgery by phacoamulsification in Feyz Hospital in Isfahan. The patient and Researcher unaware of which drugs are used for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18 to 90 years undergoing cataract surgery using phacoemulsification methods under local anesthesia and sedation in the first and second classes of the American Anesthetic Association. Exclusion criteria: history of any allergy to the drug used in the design, history of drug addiction, alcohol, benzodiazepine and pregnancy, congestive heart failure, history of head trauma, glaucoma, hypotension, evidence of increased intracranial pressure, psychosis, schizophrenia, active upper respiratory tract infection , Asthma, chronic respiratory disease.
Intervention groups
Patients in the first group (group D) will receive dexmedetomidine and patients in the second group (group M) will receive midazolam-fentanyl and in the third group (group E) atomidite for sedation during surgery. The sample size in each group was 30 people
Main outcome variables
Sedation level; drug complications; pain intensity; Arterial blood pressure; oxygen saturation; heart rate; recovery time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039326N20
Registration date: 2022-02-26, 1400/12/07
Registration timing: registered_while_recruiting

Last update: 2022-02-26, 1400/12/07
Update count: 0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cardiovascular response to sedation with dexmedetomidine, midazolam and etomidatein phacoemulsification under local anesthesia
Public title
The effect of cardiovascular response to sedation with dexmedetomidine, midazolam and atomidite in cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 35 to 85 years Patients who are candidates for phycoemolysis cataract surgery Patients undergoing local anesthesia and sedation in this surgery have Class 1 and 2 of the American Anesthesia Association Patients with controlled blood pressure
Exclusion criteria:
History of any allergy to the drug used in the design History of drug addiction, alcohol, benzodiazepine Pregnancy Congestive heart failure History of head trauma Glaucoma Hypotension Evidence of increased intracranial pressure Psychosis Schizophrenia Active upper respiratory tract infection Asthma Chronic respiratory disease
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The division of patients into two groups is based on a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blinded.Patient and researcher are unaware of patient groups and type of medication.The medications are prepared by an anesthetist who is unaware of the grouping of patients and is worn by an aluminum foil and encoded by an anesthetist.Demographic information; Sedation level. The quality of pain relief and hemodynamic variables and complications are collected by a patient who is not aware of the type of drug and patient grouping.
Placebo
Not 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
Isfahan Unoversity of medical sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
1400.674.IR.MUI.MED.REC

Health conditions studied

1

Description of health condition studied
Cataract surgery
ICD-10 code
H43.9
ICD-10 code description
Unspecified disorder of vitreous body

Primary outcomes

1

Description
Sedation level based on ramsay score
Timepoint
Every 5 minutes during surgery
Method of measurement
Ramsay score

Secondary outcomes

1

Description
Arterial pressure
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Pressure gauge

2

Description
Oxygen saturation
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Pulse oximeter

3

Description
Heart rate
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Pulse oximeter

4

Description
Intensity of pain
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Universal Pain assessment tool

5

Description
recovery time
Timepoint
After completing the intervention until the withdrawal from the recovery
Method of measurement
Minute Numbers

Intervention groups

1

Description
Intervention group: In dexmedetomidine group (D), patients will receive 1 /g / kg of dexmedetomidine in 20 ml of normal saline for 10 minutes followed by infusion of dexmedetomidine at 0.5 /g / kg / h.
Category
Treatment - Drugs

2

Description
Intervention group: In the midazolam group (M) patients will receive 0.05 mg / kg of slow intravenous midazolam
Category
Treatment - Drugs

3

Description
Intervention group: In the atomidite group (E) they will receive 0.2mg / kg. In all three groups, 1.5mcg / kg for fentanyl analgesia and 0.5mg / kg propofol with a concentration of 5mg / ml is prescribed if more sedation is needed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Feyz Hospital , Modares St
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2034
Email
Hamidshetabi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjooye Javanmard
Street address
Vice chancellor of research and technology of university, Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3668 8138
Email
Hamidshetabi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3445 2034
Email
Hamidshetabi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3445 2034
Email
Hamidshetabi@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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