A comparative study of administration of low dose ketamine with lidocaine on changes in heart rate and blood pressure during tracheal intubation under general anesthesia.
Determination and comparison of low-dose ketamine administration with lidocaine on heart rate and blood pressure changes during tracheal intubation
Design
A randomized, triple-blinding clinical trial, with the parallel groups, Phase 3 on 90 patients
Settings and conduct
In this three-blind randomized clinical trial study, 90 eligible patients referred to Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into three groups. Patients are given a low dose of ketamine, lidocaine, or normal saline, respectively. The intervention will be carried out in such a way that the patient, the researcher and the statistical analyst will not have any knowledge of the type of intervention and the triple-blind conditions will be established. Then the hemodynamic parameters and complications of the patients will be evaluated and compared among the three groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria include the age group of 18 to 65 years, the American Association of Anesthesiologists (ASA) classification equal to one or two, candidates for elective and emergency surgeries under general anesthesia, and consent to participate in the study.
Exclusion criteria include having a history of severe cardiovascular disease, having a history of arrhythmia, and having a history of taking blood pressure lowering drugs.
Intervention groups
First intervention group: patients in this group receive 0.5 mg/kg of ketamine. The second intervention group: patients in this group receive 0.5 mg/kg of lidocaine.
Control group: patients in this group do not receive any of the cases of ketamine or lidocaine (half a cc of normal saline is prescribed).
A comparative study of administration of low dose ketamine with lidocaine on changes in heart rate and blood pressure during tracheal intubation under general anesthesia.
Public title
Comparison of administration of low dose ketamine with lidocaine on changes in heart rate and blood pressure during intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 18 to 65 years
American Society of Anesthesiologists (ASA) classification equal to one or two
Candidate for elective and emergency surgeries under general anesthesia
Consent to participate in the study
Exclusion criteria:
Having a history of severe cardiovascular disease
Having a history of arrhythmia
Having a history of taking blood pressure lowering drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 90 eligible patients are randomly selected. For this, the letter A is written on 30 sheets, the letter B is written on 30 sheets, the letter C is written on 30 sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to achieve the triple-blind study, low dose of ketamine, lidocaine, and placebo will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2022-01-01, 1400/10/11
Ethics committee reference number
IR.MUI.MED.REC.1400.721
Health conditions studied
1
Description of health condition studied
Candidate patients for surgery under general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure
Timepoint
in basic times (before induction of anesthesia, anesthesia, before tracheal tube removal) and 1, 3, 5, and 10 minutes after tracheal tube removal
Method of measurement
Monitoring device
2
Description
Heart beat
Timepoint
in basic times (before induction of anesthesia, anesthesia, before tracheal tube removal) and 1, 3, 5, and 10 minutes after tracheal tube removal
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: patients in this group receive 0.5 mg/kg of ketamine.
Category
Treatment - Drugs
2
Description
Second intervention group: patients in this group receive 0.5 mg/kg of lidocaine.
Category
Treatment - Drugs
3
Description
Control group: patients in this group do not receive any of the cases of ketamine or lidocaine (half a cc of normal saline is prescribed).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
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
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?