Comparison the effect of transtracheal lidocaine and intravenous lidocaine on hemodynamic of Patients with hypertension undergoing drug treatment to tracheal intubation
The aim of this study was to compare the effects of intravenous lidocaine and transtracheal on hemodynamic changes in patients with hypertension under medical treatment following tracheal intubation.
Design
Clinical trial with control group, parallel groups, double blind, randomized with 78 patients
Settings and conduct
Patients with hypertension and candidates for delayed surgery with general anesthesia and endotracheal intubation undergone surgery at Rasoul Akram hospital. Participants were randomly assigned to three groups. Participants and outcome assessors were also unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with American Society of Anesthesiologists (ASA) grade 3 and lower.
Non-inclusion criteria: emergency surgery; drug abuse; alcohol consumption; all cases of severe intubation; diabetes, heart failure, kidney failure, taking beta blocker; initial dysrhythmia; systolic pressure more than 170 mmHg and diastolic more than 100 mmHg.
Intervention groups
Group A (intravenous lidocaine), Group B (lidocaine transtracheal) and Group C (non-use of lidocaine)
Comparison the effect of transtracheal lidocaine and intravenous lidocaine on hemodynamic of Patients with hypertension undergoing drug treatment to tracheal intubation
Public title
Effect of transtracheal lidocaine and intravenous lidocaine on hemodynamic of Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with American Society of Anesthesiologists (ASA) grade 3 and lower
Exclusion criteria:
Emergency surgery
Drug abuse
Alcohol consumption
All cases of difficult intubation
Diabetes
Heart failure
Kidney failure
Taking beta blocker
Primary dysrhythmia
Systolic pressure more than 170 mmHg
Diastolic more than 100 mmHg
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
82
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly divided into intervention and control groups using a lottery method. As the names of all participants are placed inside the container. The names are drawn out from the container, respectively, and placed in the intervention and control groups. At the end, the papers containing the names are opened and different groups are determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome evaluators were not aware of the intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemat Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.154
Health conditions studied
1
Description of health condition studied
Hemodynamic changes in patients with hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
After 4 minutes, patients with appropriate endotracheal tube and 30 seconds after intubation were recorded, at 3, 6 and 9 minutes after intubation, blood pressure and heart rate.
Method of measurement
Mercury barometer
2
Description
Heart rate
Timepoint
After 4 minutes, patients with appropriate endotracheal tube and 30 seconds after intubation were recorded, at 3, 6 and 9 minutes after intubation, blood pressure and heart rate.
Method of measurement
Mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In group A, fentanyl 2 mg/kg and intravenous lidocaine 2% 1.5mg/ kg was injected and anesthetized by thiopental 4 mg/kg and cisatracurium 0.2 mg/kg. Then, 30 seconds after the induction, blood pressure and heart rate were recorded After 4 minutes, the patient was intubated by an appropriate tracheal tube and 30 seconds after the intubation, blood pressure and heart rate were recorded again, and then, at minutes 3, 6 and 9 after intubation, the patient's blood pressure and heart rate were recorded. In all monitoring registers, any incidence of dysrhythmia was recorded in the ECG.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the group B, fentanyl 2 mg/kg was injected intravenously and anesthetized by thiopental 4 mg/kg and cisatracurium 0.2 mg/kg. Then, 30 seconds after the induction, blood pressure and heart rate were recorded and lidocaine 2% 1.5mg/ kg was injected as transtracheal. After 4 minutes, the patient was intubated by an appropriate tracheal tube and, similar to group A, at specified times, blood pressure and heart rate were recorded. Lidocaine was injected in the both ways 90 seconds before intubation.
Category
Treatment - Drugs
3
Description
Control group: In the group C, the only difference with other groups was the lack of use of lidocaine.