Determining the effect of remifentanil on hemodynamic response to laryngeal mask airway insertion In induction of anesthesia with propofol in combination with fentanyl or ketamine
Design
This study is a double-blind randomized clinical trial performed on 44 patients undergoing cataract surgery. Patients using
Random allocation software will be allocated to two groups receiving fentanyl-propofol and ketamine-propofol.
Remifentanil is given at the same time in both groups.
Settings and conduct
In this study, the effect of remifentanil on hemodynamic response to laryngeal mask airway insertion induction of anesthesia with propofol combined with fentanyl and ketamine is evaluated in cataract surgery.
The patient, anesthesiologist, and data collector are unaware of the drug grouping.
Patients are randomly assigned to one of the two groups of fentanyl 1 mcg/kg and ketamine 0.5mg / kg. Propofol 1mg / kg and remifentanil 0.5mcg / kg will prescribed in both
The study site is Faiz Hospital in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA class I and II candidates for cataract surgery with aged 30 to 85 years
Non-inclusion criteria: Poor mouth opening Pharyngeal pathology Laryngeal pathology Pulmonary diseases Risk of aspiration (full stomach, gastroesophageal reflux disease, pregnancy) History of allergy to any anesthetic drugs High airway resistance
Intervention groups
Two intervention groups:
The first group received propofol 1mg / kg, fentanyl 1µ / kg and remifentanil 0.5mic / kg
The second group received propofol 1mg / kg, ketamine 0.5mg / kg and remifentanil 0.5mic / kg.
Study of remifentanil effect on hemodynamic respons to arrange LMA in anesthesia induction with propofol and fentanil or ketamin
Public title
Study of remifentanil effect on hemodynamic respons to arrange LMA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class I and II ASA patients
Candidate for cataract surgery under general anesthesia
Adults (30 to 85 years)
Exclusion criteria:
Patient dissatisfaction,
Weight less than 40 or more than 110 kg,
Existence of cervical vertebrae,
Age
From 30 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are randomly assigned to two intervention groups and assigned using Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, surgeon, anesthesiologist, and observer of the results were unaware of the grouping of patients.
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
Hezarjarib Blvd, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.MUI.MED.REC.1397.286
Health conditions studied
1
Description of health condition studied
Cataract surgery
ICD-10 code
Z98.4
ICD-10 code description
Cataract extraction status
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before induction of anesthesia, immediately before laryngeal mask implantation and at 1, 3 and 5 minutes after LMA placement and fixation
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: Ventanil, in this group, syringes containing 1 mg / kg propofol and 1µ / kg fentanyl are injected into people.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group 2: Ketamine, in this group, the syringe contains 1 mg / kg propofol and 0.5 mg / kg ketamine for injection in individuals.
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 haqjou javanmard
Street address
Vice chancellor of research and technology of university.Isfahan University of Medical Sciences. Hezarjarib St
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
8817976155
Phone
+98 31 3620 2020
Fax
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital. Modares St
City
Isfahan
Province
Isfehan
Postal code
8817976155
Phone
+98 31 3620 2020
Fax
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz Hospital. Modares St
City
Isfahan
Province
Isfehan
Postal code
8817976155
Phone
+98 31 3620 2020
Fax
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