Comparison of the sedative effect of ketamine propofol 1: 3 and fentanyl propofol in cataract surgery by phacoamulsification method
Design
Clinical trials in two community-based and pragmatic groups with blind, randomized 100-person parallel groups
Settings and conduct
The use of two different drugs with specific doses in two 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
First intervention group: Combination of ketamine propofol 1: 3 and Second intervention group: combination of fentanyl-propofol to measure sedation levels in comparison with other drugs used in cataract surgery
Main outcome variables
relaxation ; Drug side effects; Average heart rate; Average arterial pressure; Average oxygen saturation; Mean pain severity; Average recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N2
Registration date:2018-07-18, 1397/04/27
Registration timing:retrospective
Last update:2018-07-18, 1397/04/27
Update count:0
Registration date
2018-07-18, 1397/04/27
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
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
empty
Scientific title
Comparison of sedative efficacy of ketamine propofol 1 to 3 and fentanyl propofol in cataract surgery by phacoamulsification method
Public title
Relaxation of Ketamine Propofol and Fentanyl Propofol in Cataract Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cataract surgery by phacoamulsification
Exclusion criteria:
.History of any allergy to anesthetic drugs
Congestive Heart Failure
Cardiac arrest
Glaucoma
Hypotension
Chronic respiratory disease
Psychosis
Schizophrenia
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
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 Universiti of Medical Sciences
Street address
Feiz Hospital . Modares st
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.MUI.REC.1396.3.627
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
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Ramsay score
Secondary outcomes
1
Description
arterial pressure
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Pressure gauge
2
Description
Heart rate
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Oximetry pulse
3
Description
Surgeon Satisfaction
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Likert questionnaire
4
Description
Percent saturation of oxygen
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Oximetry pulse
Intervention groups
1
Description
Intervention group: first: the combination of Ketamine- propofol.Syringe 2 contains pethidine (0.2 mg / kg) with distilled water at a concentration of 5cc (concentration 10mg / cc). Propofol containing 0.6mg / kg Propofol (5mg / cc) and Propofol 4 (5mg / cc) will be administered. Group 1 (Kp) Firstly, the syringe 2 is injected into the header and then injected into the header 3 of the syringe 3 as a 3 or 4 sedation level of ramsay score. In the course of surgery, if you need a deeper sedation than Syringe 4 in 1cc volumes as the dose of salvage and total dose It is recorded.
Category
Treatment - Drugs
2
Description
Intervention group: second: the combination of fentanyl- propofol. Syringe 1 contains fentanyl 2 mcg / kg, which is added by adding 5 cc water. Syringe 3 contains Propofol 0.6 mg / kg at 5 mg / cc and 4 Propofol, 5 mg / cc concentration. In group 1 (PF), the first syringe 1 is injected into the titre. Then, in each case, the syringe number 3 is injected into the titer of the sedation level of 3 or 4 ramsay. At the same time, if necessary, a deep sedation needing a syringe number 4 in 1 cc volumes is recorded as a dental carriage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faiz Hospital
Full name of responsible person
Morteza heidari
Street address
feiz hospital ، modares st
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3445 2034
Email
M_Heidari@med.mui.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaqayeq haqjou javanmard
Street address
Hizar jarib st - Isfahan University of Medical Sciences and Health Services - Deputy of Research and Technology of the University
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 5149
Email
sh_haghjoo@med.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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital ، Modares St
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
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
Morteza heidari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital , Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 5555
Email
m_heidari@med.mui.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital ، Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
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