Comparison the prevalence of sore throat due to endotracheal intubation with videolaryngoscope (Glidoscope) and conventional laryngoscope Macintosh and placement the LMA in elective surgeries
Comparison the prevalence of sore throat due to endotracheal intubation with videolaryngoscope (Glidoscope) and conventional laryngoscope Macintosh and placement the LMA in elective surgeries
Design
Study design: clinical trial.
Number of groups: 3
Total sample size: 90 patients.
Sample size in each group: 30 people
Randomization: random packs that opened precisely before the start of surgery.
Blinding: a person outside the study and unaware of the study process (double-blind study).
Settings and conduct
Location: Shahid Rajaee & Velayat hospitals in Qazvin city, Iran.
Study Methods: patients were randomly assigned to one of the study groups. Patient's monitoring was performed using ECG (electrocardiogram), pulse oximetry and barometric measurements. All patients received 2 mg/kg body weight fentanyl and 0.2 mg/kg body weight midazolam as a precursor and then propofol was given at a dose of 2.5-2 mg / kg body weight and atracurium at a dose of 0.5 mg/kg of body weight, anesthetic induction was prescribed. Patients were treated with 100% oxygenation mask for 3 minutes; then the G group was subjected to intubation with blade number 3; the M group was also implanted with blade 3 of the Macintosh laryngoscope and the L group was placed under the LMA placement. After fixing the tube or LMA, an oxygen concentration of 100% plus TIVA (propofol infusion) was administered to each of the three groups of patients for anesthesia (N2O not prescribed for any patient), and repeated fentanyl injection was used for maintaining analgesia. The number of patients with sore throat in the 8-6 hours and 24 hours after surgery was recorded in all three groups using questionnaire. The length of the laryngoscopy (that is measured by the number of seconds from the time the laryngoscope enters the mouth, until the tracheal tube passes) was recorded via vocal cords.
For each patient, the duration of the laryngoscopy until the insertion of the tracheal tube and the number of attempts to intubate by seconds were measured and recorded. The length of the LMA placement was measured and recorded from the time it was inserted into the mouth until it was placed in Pharenx. Also in all patients, hemodynamic parameters including heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure were recorded one minute before induction of anesthesia and also in the 3rd and 5th minutes after intubation or LMA insertion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: presence of ASA (American Society of Anesthesiology Status) Class I or II; age between 20 to 40 years old; patients undergoing any elective surgery (except for head and neck surgery) and requiring general anesthesia.
Non-admission criteria: aspiration and vomiting during induction of anesthesia and laryngoscopy; the presence of any lesion or active disease in the head and neck area and the airway such as pharyngitis or laryngeal mass during pre-anesthetic visit; head and neck surgery; cardiovascular, respiratory, neovascular and cardiovascular and rheumatic disorders; high risk of aspirating (diabetic patients, incomplete NPO time, addicted patients); history of difficult Intubation
Length of surgery for more than 2 hours; possible problems for intubation in the clinical examination; length of intubation or LMA insertion time greater than 20 seconds.
Intervention groups
1) Direct laryngoscopy group via Macintosh blade (M)
2) ]ndirect laryngoscopy group via gladioscope (G)
3) Group (L) by inserting LMA
Main outcome variables
Sore throat at intervals of 8-6 hours and 24 hours after intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180207038661N1
Registration date:2018-02-18, 1396/11/29
Registration timing:retrospective
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Mohammad Ali Masoumifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 0107
Email address
mebtehaj@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
2017-06-23, 1396/04/02
Actual recruitment end date
2017-12-15, 1396/09/24
Trial completion date
empty
Scientific title
Comparison the prevalence of sore throat due to endotracheal intubation with videolaryngoscope (Glidoscope) and conventional laryngoscope Macintosh and placement the LMA in elective surgeries
Public title
Comparison sore throats caused by the three main techniques of intracranial intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of ASA (American Society of Anesthesiology Status) Class I or II
Age between 20 to 40 years old
Patients undergoing any elective surgery (except for head and neck surgery) and requiring general anesthesia.
Exclusion criteria:
Aspiration and vomiting during induction of anesthesia and laryngoscopy
The presence of any lesion or active disease in the head and neck area and the airway such as pharyngitis or laryngeal mass during pre-anesthetic visit
Head and neck surgery
Cardiovascular, respiratory, neovascular and cardiovascular and rheumatic disorders
High risk of aspirating (diabetic patients, incomplete NPO time, addicted patients)
History of difficult Intubation
Length of surgery for more than 2 hours
Possible problems for intubation in the clinical examination
Length of intubation or LMA insertion time greater than 20 seconds
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization and placement of patients in one of the study groups we used random packets. In this way, the researcher randomly opened one of the envelopes before the anesthetic induction and at that moment the technique was chosen for the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Packets used for randomization, were prepared by someone else who were not included in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Bulivard, Qazvin, Iran