The aim of this study is to determine if adding lidocaine to propofol is effective in sedating patients undergoing bronchoscopy.
Design
Interventional Clinical trial , two parallel groups, triple blinded, randomised study, phase 3 study on 60 patients
Settings and conduct
This study will be done on patients undergoing bronchoscopy in al zahra hospital in winter of 1402 and spring of 1403. Patients, researcher and data analyst are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria; 1. Age between 18 and 60
2. American Society of Anesthesiologists(ASA) physical status classification system class I or class II
3. Bronchoscopy candidate both genders
Exclusion Criteria: 1. Opioid or analgesic usage 24 hours before procedures
2. History of beta blocker usage
3. Allergy to drugs
4. Patients with severe cardiovascular diseases, asthma, renal disease, hepatic disease, chronic respiratory disease
5. Immunodeficiency
6. Alcohol consumption 24 hours before procedure
7. Muscular weakness
Intervention groups
Group 1; propofol group
for each patient an stat dose of propofol 1 mg/kg is calculated and then injected. After the initial induction if sedation score 5 is not achieved, propofol infusion with the rate of 70 µg/kg/min will be started. The amount of drug used to achieve and maintain Sedation Score 5 will be calculated.
Groip 2; lidocaine-propofol combination
for each patient an stat dose of propofol 1mg/kg and lidocaine 1.5 mg/kg is calculated and then injected. After the initial induction if sedation score 5 is not achieved, propofol infusion with the rate of 70 µg/kg/min will be started.The amount of drug used to achieve and maintain Sedation Score 5 will be calculated.
Comparison of propofol sedation and lidocaine-propofol combination in patients undergoing bronchoscopy
Public title
Comparison of propofol sedation and lidocaine-propofol combination in patients undergoing bronochoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum 18 years of age and maximum 60
ASA I or ASA II group of patients
Bronchoscopy candidate either male or female
Exclusion criteria:
Analgesics or Opioid use 24 hours before procedure
Previous use of Beta blockers
Any known allergy to drugs used in this trial
Patients with a past medical history of severe cardiovascular diseases, Asthma, Renal disease, Hepatic disease, chronic respiratory disease
Past history of Drug Allergy
Immunodeficiency
Alcohol consumption 24 hours before procedure
Muscular weakness
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization in this trial will be simple random sampling
Blinding (investigator's opinion)
Triple blinded
Blinding description
This will be a triple blinded study. Drugs will be prepared by OR staff in syringes labeled with specific codes and then handed to the researcher. therefore the patient and the researcher won't know the difference. The data will be given to the data analyst who is also blinded.
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
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-01-07, 1402/10/17
Ethics committee reference number
IR.MUI.MED.REC.1402.369
Health conditions studied
1
Description of health condition studied
Anaesthesia
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
Primary outcomes
1
Description
Heart rate
Timepoint
Before induction, 3 minutes after induction, 10 minutes after induction, 20 minutes after induction
Method of measurement
پالس اکسیمتری
2
Description
Blood Pressure
Timepoint
Before induction, 3 minutes after induction, 10 minutes after induction, 20 minutes after induction
Method of measurement
non invasive manometer
Secondary outcomes
1
Description
sedation level
Timepoint
Before induction, 3 minutes after induction, 10 minutes after induction, 20 minutes after induction
Method of measurement
Sedation Score
Intervention groups
1
Description
Propofol; for each patient an stat dose of propofol 1 mg/kg is calculated and then injected. After the initial induction if sedation score 5 is not achieved, propofol infusion with the rate of 70 µg/kg/min will be started. The amount of drug used to achieve and maintain Sedation Score 5 will be calculated.
Category
Treatment - Drugs
2
Description
Propofol-Lidocaine, for each patient an stat dose of propofol 1mg/kg and lidocaine 1.5 mg/kg is calculated and then injected. After the initial induction if sedation score 5 is not achieved, propofol infusion with the rate of 70 µg/kg/min will be started. The amount of drug used to achieve and maintain Sedation Score 5 will be calculated.