Effect of lidocaine solution versus dexmedetomidine on gag reflex during propofol-based sedation for patients undergoing upper gastrointestinal endoscopy
Determining the effectiveness of lidocaine solution and dexmedetomidine on gag reflex in upper endoscopy patients under anesthesia with propofol
Design
Clinical trial, with parallel groups, without blinding, phase three, randomized, which will be conducted on 126 patients randomly.
Settings and conduct
The studied population are patients aged 18-60 who are candidates for endoscopy, referring to Ayatollah Rouhani Babol educational and therapeutic center. Patients are randomly divided into three intervention groups using a computer and the intervention will be performed on them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-60 years and American Society of Anesthesiologists Classification (ASA class) 1-2
Exclusion Criteria: cardiovascular diseases; respiratory diseases; mental-psychological diseases; patients with a history of allergies and emergency patients.
Intervention groups
Intervention group1: 50 mg of propofol (Shefafarmed) slowly intravenously over 1 minute.
Intervention group2:At First, 0.5 micrograms/Kg along with dexmedetomidine (Arang Daro) intravenously, followed by 50 mg of propofol (Shefafarmed) intravenously within 1 minute.
Intervention group3: 1cc of lidocaine solution (Elixir Pharmaceuticals) 2% 3 to 5 minutes before endoscopy by pushing aside the tongue with the help of a sling in the pharynx area.
Main outcome variables
Gag Reflex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044907N5
Registration date:2023-09-28, 1402/07/06
Registration timing:prospective
Last update:2023-09-28, 1402/07/06
Update count:0
Registration date
2023-09-28, 1402/07/06
Registrant information
Name
seyed hossein hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 3301
Email address
a.hamidi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lidocaine solution versus dexmedetomidine on gag reflex during propofol-based sedation for patients undergoing upper gastrointestinal endoscopy
Public title
Determining the effectiveness of lidocaine solution and dexmedetomidine on gag reflex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years
American Society of Anesthesiologists Classification (ASA class) 1-2
Exclusion criteria:
Cardiovascular Diseases
Respiratory Diseases
Mental illnesses
Patients with a history of allergies
Emergency patients
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using permutation blocks of size 6. (AABBCC) in such a way that the blocks of 6 consist of random combinations of 2 to A (Propofol), B (Dexmedetomidine) and C (Propofol+Lidocaine). will be randomly assigned to three groups of 42 people. Creating a random sequence in the blocks will be done by a statistician.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Siences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-09-17, 1402/06/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.095
Health conditions studied
1
Description of health condition studied
Gag Reflex
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Gag Reflex
Timepoint
5, 10 and 15 minutes after the endoscope is removed from the patient's mouth
Method of measurement
Criteria for measuring the severity of nausea: No nausea: No gag during contact with high risk surfaces of the mouth such as soft palate and tonsils Hakm: Gag formation during contact with high risk surfaces of the mouth such as soft palate and tonsils Medium: Gag formation during contact with low levels Risk of mouth such as hard palate and hard floor: Creating a gag before contact with an abscess, such as when opening the mouth and seeing an abscess
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: 50 mg of propofol (Shefafarmed) slowly intravenously over 1 minute
Category
Treatment - Drugs
2
Description
Intervention group2: At First, 0.5 micrograms/Kg along with dexmedetomidine (Arang Daro) intravenously, followed by 50 mg of propofol (Shefafarmed) intravenously within 1 minute.
Category
Treatment - Drugs
3
Description
Intervention group3: 1cc of lidocaine solution (Elixir Pharmaceuticals) 2% 3 to 5 minutes before endoscopy by pushing aside the tongue with the help of a sling in the pharynx area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Seyed Hossein Hamidi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
s.hosseinhamidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?