Evaluation of the effect of non-depolarizing muscle relaxant on the facilitation of laryngeal mask airway insertion
Design
This randomized double-blind clinical trial phase 3 study with parallel groups conducted on 40 patients undergoing elective surgery under general anesthesia. Patients were randomly divided into intervention and control groups based on generated computer numbers.
Settings and conduct
In this study, patients candidates for elective surgery in Urmia Imam Khomeini hospital under general anesthesia were included. The patient, outcome assessor, and anesthesiologist were blind to the belonging of the patients to the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age group between 20 to 70 years; Classes I and II of the American Anesthesiology Society (ASA I and ASA II) and patients were candidates for elective surgery under general anesthesia. Exclusion criteria: obesity; a history of cervical spine disease; a history of drug and food allergies; congenital or acquired abnormalities in the face and airways and a history of seizures.
Intervention groups
Patients were randomly divided into two groups based on generated computer numbers. In both groups, firstly 1 mg intravenous midazolam and 2 μg intravenous fentanyl were administered per kg body weight, then patients in the intervention group received 3 mg /kg intravenous propofol with 0.1 mg/ kg intravenous atracurium and in the control group received 3 mg / kg intravenous propofol with 2 cc of intravenous normal saline.
Main outcome variables
Number of attempts to successfully LMA insertion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201207049639N4
Registration date:2021-01-08, 1399/10/19
Registration timing:retrospective
Last update:2021-01-08, 1399/10/19
Update count:0
Registration date
2021-01-08, 1399/10/19
Registrant information
Name
Hadi Houshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
hooshyar.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2019-12-21, 1398/09/30
Scientific title
Evaluation of the effect of non-depolarizing muscle relaxant on the facilitation of laryngeal mask airway insertion
Public title
The effect of muscle relaxant on the facilitation of laryngeal mask airway insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group between 20-70 years
Patients candidates for elective surgery under general anesthesia
American Society of Anesthesiologists classification system I and II (ASA II and ASA II)
Exclusion criteria:
Obesity
History of cervical spine disease
History of drug and food allergies
Congenital or acquired abnormalities in the face and airways
History of seizures
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and control groups using Random allocation computer software.By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients allocated into two groups according computer generated numbers. This software according to the total sample size, assigns numbers to patients up to the determined total sample size in order from number one. For example, it determines that the first patient is in the intervention group and the next patient can be in the intervention or control group. But finally the number of patients in the two groups will be equal. Based on the list of generated numbers by the software, patients were divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double-blind clinical trial. The patient, outcome assessor, and the anesthesiologist who administered the drugs to the patients were blind about the type of drug and the study groups. The syringes containing the intervention or placebo were given a code and these codes were recorded for each patient. An anesthesiologist (other than the researcher) was aware of the codes, and the person who evaluated the outcomes did not know the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Street, Jahad Ave, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.UMSU.REC.1398.066
Health conditions studied
1
Description of health condition studied
Facilitate of insertion laryngeal mask airways (LMA)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The number of attempts for successfully LMA insertion
Timepoint
During the insertion of laryngeal mask
Method of measurement
The number of attempts
Secondary outcomes
1
Description
Sore throat
Timepoint
After the laryngeal mask insertion
Method of measurement
Clinical examination
2
Description
Laryngospasm
Timepoint
After the laryngeal mask insertion
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: Patients in the intervention group after receiving of intravenous midazolam 1 mg and Intravenous fentanyl 2 mg, they received 3 mg / kg of intravenous propofol with 0.1 mg / kg of intravenous atracurium.
Category
Treatment - Surgery
2
Description
Control group: Patients in the control group after receiving of intravenous midazolam 1 mg and Intravenous fentanyl 2 mg, they received 3 mg / kg of intravenous propofol with 2 cc of intravenous normal saline.