Investigating the effects of the simultaneous administration of transtracheal block and tropical anesthesia of glossopharyngeal nerve on hemodynamic change during intubation in awake patients with laryngeal cancer
Determining the effect of simultaneous transtracheal nerve block and topical anesthesia on hemodynamic changes during awake intubation
Design
A randomized clinical trial, 30 cases and 30 controls
Settings and conduct
Before intubation, the following will be pursued: Electrocardiography, Blood pressure measurement, Pulse oximetry, Secure IV line, Ringer lactate, Glycopyrrolate administration 0.2 mg before the procedure, Midazolam administration 1 mg 5 min before the procedure, Butorphanol administration 2 mg right before the procedure, Spraying 40 mg Lidocaine 10% in the oropharynx. A BP of 120/80 up to 140 /90 and a heart rate of 60-100 will be considered the normal range. The intervention will be conducted once. 30 patients in the intervention group will undergo ُُSimultaneous transtracheal block and topical anesthesia of the glossopharyngeal nerve during awake intubation and 30 patients will receive topical glossopharyngeal nerve block as the control group. For transtracheal nerve block, a needle will penetrate the cricothyroid membrane and after aspiration, 4 ccs of lidocaine 2% will be injected. For topical anesthesia, topical lidocaine 10% will be sprayed 5 puffs at the posterior of the tongue bilaterally and at pharyngeal folds.
Participants/Inclusion and exclusion criteria
Patients with laryngeal cancer will be interviewed for inclusion and those who voluntarily fill out the informed consent form will be found eligible for inclusion. Those with a past history of asthma, allergy, or under anticoagulants will be excluded. Those with unstable hemodynamic changes such as bradycardia will be excluded. Patients with active infections will be excluded.
Intervention groups
ُُSimultaneous transtracheal block and topical anesthesia of glossopharyngeal nerve during awake intubation
Main outcome variables
Changes in patients' blood pressure, heart rate, and oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220518054912N1
Registration date:2022-06-29, 1401/04/08
Registration timing:prospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
pedram sarlaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 1226
Email address
pedramsarlaki@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of the simultaneous administration of transtracheal block and tropical anesthesia of glossopharyngeal nerve on hemodynamic change during intubation in awake patients with laryngeal cancer
Public title
The effects of the simultaneous administration of transtracheal block and tropical anesthesia of glossopharyngeal nerve on hemodynamic change during intubation in awake patients with laryngeal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with laryngeal caner who are candidates for awake intubation
Exclusion criteria:
Patients with a history of asthma or allergy or under anticoagulants
Patients with unstable hemodynamic status (such as bradycardia)
Patients with active infections
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization, conducted using random numbers chart, and assigning random numbers to patients with 30 patients randomly assigned to the intervention group and 30 patients will be randomly assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz boulevard, Central building of the Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-06-06, 1400/03/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.234
Health conditions studied
1
Description of health condition studied
Laryngeal Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in pulse rate, oxygen saturation level, and blood pressure during awake intubation in patients with laryngeal cancer
Timepoint
During the intervention
Method of measurement
Barometer and pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Simultaneous administration of trans-tracheal nerve block and topical anesthesia on glossopharyngeal nerve
Category
Treatment - Other
2
Description
Control group: Glossopharyngeal nerve block with oral injection of the Lidocaine 2%
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirAlam Hospital Complex
Full name of responsible person
Pedram Sarlaki
Street address
Enghelab Ave., North Saadi Street
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 8103
Email
Amiralam.ipd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Street address
Anesthesia Department of AmirAlam Hospital, North Saadi Street
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6634 3352
Email
hamiralam@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pedram Sarlaki
Position
Student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
No 8 . negarestan 4. Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946964115
Phone
+98 21 2286 1226
Fax
Email
pedramsarlaki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pedram Sarlaki
Position
Student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
No 8 . negarestan 4. Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946964115
Phone
+98 21 2286 1226
Fax
Email
pedramsarlaki@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pedram Sarlaki
Position
Student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
No 8 . negarestan 4. Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946964115
Phone
+98 21 2286 1226
Fax
Email
pedramsarlaki@yahoo.com
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