Anesthetizing epiglottis and vocal cords for prevention of blood pressure elevation after endotracheal intubation in patients with uncontrolled hypertension
Design
Double-blind randomized clinical trial
Settings and conduct
Intervention group 1: Patients receive 1.5 mg per kg diluted lidocaine up to 10 cc for spray with nalton catheter on vocal cords and epiglottis.
Intervention group two: Patients receive ten cc of lidocaine 1.5 mg per kgdiluted for intravenous injection.
Intervention group three: Patients receive remifentanil 1 μg per kg diluted up to 10 cc for intravenous injection.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients over 18 years, Uncontrolled blood pressure Candidates for elective surgery under general anesthesia with endotracheal tube.
Exclusion Criteria: Patients who are hypersensitive to any of the drugs lidocaine or remifentanil, Patients who need rapid sequence induction, mallampati 3,4, difficult intubation, Consumption of beta blocker, Patients who need to receive antihypertensive medication due to a significant increase in blood pressure during surgery.
Intervention groups
Intervention group 1: Patients receive 1.5 mg per kg diluted lidocaine up to 10 cc for spray with nalton catheter on vocal cords and epiglottis.
Intervention group two: Patients receive ten cc of lidocaine 1.5 mg per kgdiluted for intravenous injection.
Intervention group three: Patients receive remifentanil 1 μg per kg diluted up to 10 cc for intravenous injection.
Main outcome variables
Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N116
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-18, 1400/01/29
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of intravenous and local lidocain and remifentanil on hemodynamic changes during tracheal intubatin in hypertensive patients
Public title
Comparison effects of intravenous and local lidocain and remifentanil on hemodynamic changes during tracheal intubatin in hypertensive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years
ASA 2-3
Uncontrolled blood pressure
Patients who are candidate for elective surgery under general anesthesia with endotracheal tube
Exclusion criteria:
Patients who are hypersensitive to any of the drugs lidocaine or remifentanil
Patients who need rapid sequence induction
Mallampati 3,4
Difficult intubation
Consumption of beta blocker
Patients who need to receive antihypertensive medication due to a significant increase in blood pressure during surgery
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
By simple randomization and number extraction in triplicate blocks from www.sealedenvelope.com and an anesthesia nurse who has no role in the study will divide patients into three groups one, two and three.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know the type of group assignment.
In order to blind the anesthesiologist who is in charge of collecting data, an anesthesiologist who is aware of the conditions of study and grouping of patients, prepares the drugs and gives them to the anesthesiologist and the anesthesiologist is not aware of the type of drug in the syringe.
In all three groups, patients receive an intravenous injection and a topical drug administration to the vocal cords and epiglottis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.SUMS.MED.REC.1399.462
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
After endotracheal intubation and after removal
Method of measurement
monitoring
2
Description
Heart rate changes
Timepoint
After endotracheal intubation and after removal
Method of measurement
monitoring
3
Description
آریتمی قلبی
Timepoint
After endotracheal intubation and after removal
Method of measurement
monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two similar 10 cc syringes marked with labels A and B. Syringe A containing 1.5 mg / kg lidocaine diluted to 10 cc for spraying with nelaton catheter on the vocal cords and epiglottis and B syringe containing 10 cc Distilled water for intravenous injection.
Category
Prevention
2
Description
Intervention group: Two similar 10 cc syringes marked with labels A and B. Syringe A containing 10 cc of distilled water for spraying with a nalton catheter on the vocal cords and epiglottis and syringe B containing 10 cc of lidocaine 1.5 mg / ml Diluted kg for intravenous injection.
Category
Prevention
3
Description
Intervention group: Two similar 10 cc syringes marked with labels A and B. Syringe A containing 10 cc of distilled water for spraying with a nalton catheter on the vocal cords and epiglottis and syringe B containing remifentanil 1 μg / kg diluted to 10 cc for intravenous injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Nooshin Reza Alizadeh
Street address
Khalili St, Khalili Educational and Medical Center
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3629 1470
Email
khalili@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaieanzadeh
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
خیابان زند، طبقه هفت
Phone
+98 71 3647 4270
Email
vcrd@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nushin Reza Alizadeh
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
nushin.alizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Hadavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street