Comparison of the effect of intra nasal remifentanil and lidocaine on heart rate and blood pressure during using laryngeal mask airway in induction of anesthesia with thiopental sodium
Comparison of the effect of intra nasal remifentanil and lidocaine on heart rate and blood pressure during using laryngeal mask airway in induction of anesthesia with thiopental sodium
Design
A double-blind randomized clinical trial with a total sample size of 60 patients
Settings and conduct
After approval of this study by the Ethics Committee of Isfahan University of Medical Sciences and informed consent of 60 eligible patients aged 18-80 years undergoing elective cataract surgery in Faiz Isfahan Medical Center in this prospective randomized double blind study.
Patients were randomly divided into two groups of patients (lidocaine (1.5mg / kg) or fentanyl (1mg / kg) after induction of general anesthesia with 1.5mg / kg of fentanyl and 5mg / kg / IV of thiopental fentanyl intranasal). 1mcg / kg (Inf group) or intranasal lidocaine, 1.5mg / kg (Inl group) up to 2cc volume.For each heart rate group [HR], systolic blood pressure [SBP], diastolic blood pressure [DBP], mean arterial pressure [MAP], and blood oxygen saturation [SPO2] at three different intervals; before drug administration, during the intervention A blind observer was recorded every 5 minutes and every 10 minutes in the recovery room.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients Candidate for Laryngeal Mask (18 to 85 years)
Exclusion criteria:Risk of aspiration (gastric ulcer, gastroesophageal reflux disease, pregnancy), weight less than 40kg, 110kg, presence of pharyngeal oropharyngeal, inadequate pulmonary compliance, high airway resistance, cervical vertebrae, Sensitivity to any of the anesthetic drugs, and a history of musculoskeletal disease
Intervention groups
Group 1: Intranasal Remifentanil intake. Group 2: Intranasal Lidocaine intake
Comparison of the effect of intra nasal remifentanil and lidocaine on heart rate and blood pressure during using laryngeal mask airway in induction of anesthesia with thiopental sodium
Public title
Comparison of the effect of intra nasal remifentanil and lidocaine on heart rate and blood pressure during using laryngeal mask airway in induction of anesthesia with thiopental sodium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Candidate for Laryngeal Mask (18 to 85 years)
Exclusion criteria:
Risk of aspiration (gastric ulcer, gastroesophageal reflux disease, pregnancy), weight less than 40kg, 110kg, presence of pharyngeal oropharyngeal, inadequate pulmonary compliance, high airway resistance, cervical vertebrae,, Sensitivity to any of the anesthetic drugs, and a history of musculoskeletal disease
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The drugs are prepared by an anesthesiologist who did not know the patient group. Each patient receives a code by random allocation software and the codes are opened after the plan is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared by an anesthesiologist who did not know the patient group. Each patient receives a code by random allocation software and the codes are opened after the plan is completed.
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 University of medical sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.MUI.MED.REC.1398.509
Health conditions studied
1
Description of health condition studied
Heart rate and blood pressure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 after laryngeal mask airway
Method of measurement
Electrocardiogram (EKG)
2
Description
Blood pressure
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 after laryngeal mask airway
Method of measurement
Pressure gauge
3
Description
Mean arterial pressure
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 after laryngeal mask airway
Method of measurement
Pressure gauge
4
Description
Oxygen saturation percentage
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 after laryngeal mask airway
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients receive 5 ml / kg of Ringer fluid before induction of anesthesia and oxygen. After induction of general anesthesia with 5ml / kg intravenous thiopental sodium,they received 1mcg / kg intranasal remifentanil.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients receive 5 ml / kg of Ringer fluid before induction of anesthesia and oxygen.After induction of general anesthesia with 5 ml / kg of intravenous thiopental sodium, they received 1.5ml / kg intranasal lidocaine.
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 Haghjoo javanmard
Street address
Hizar jarib BLVD, Isfahan University of Medical Sciences and Health Services , Deputy of Research and Technology of the University
City
Isfahan
Province
Isfehan
Postal code
8174673461
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, Modarres St
City
Isfahan
Province
Isfehan
Postal code
7346181764
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 Shetsbi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
81764734610
Phone
+98 31 3620 2020
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
Feiz Hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
81764734610
Phone
+98 31 3620 2020
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