A comparison of Succinylcholine and Rocuronium effects on the rate of emergence agitation when awakening in patients undergoing direct diagnostic laryngoscopy under general anesthesia
Determining the difference, severity and duration of agitation and the incidence of myalgia in patients undergoing rapid induction with Succinylcholine in general anesthesia compared with Rocuronium
Design
Forty-eight patients aged 20 to 50 years with a risk of ASA1-2 anesthesia will be randomly divided into two groups: succinylcholine and rocuronium. After surgery, the degree of agitation when waking up in both groups was recorded according to RIKER criteria. The results will be analyzed using SPSS software.
Settings and conduct
48 patients aged 20 to 50 years with risk of ASA1-2 anesthesia who will refer to Rasoul Akram Hospital for direct diagnostic laryngoscopic surgery and will be subjected to endotracheal intubation in two groups by rapid sequencing method. The first group for premedication Will receive 3 μg/kg fentanyl and 0.5 mg / kg lidocaine and will be induced with 1 mg/kg succinylcholine and 5 mg/kg Nesdonal.
The second group for premedication will receive 3 μg/kg of fentanyl and 0.5 mg/kg of lidocaine and will be induced with 0.6 mg / kg rocuronium and 5 mg/kg Nesdonal.
In the second group, patients receive rocuronium instead of succinylcholine.
Participants/Inclusion and exclusion criteria
- Patients aged 20 to 50 years at risk of ASA1-2 anesthesia will be referred for diagnostic laryngoscopy surgery.
- Patients with a history of burns, peritonitis, hyperkalemia, renal and hepatic insufficiency, malignant hyperthermia, pseudocholinesterase deficiency, addiction, a history of benzodiazepines, and a history of psychiatric illness will not be included in the study.
Intervention groups
Patients are divided into two intervention groups receiving Succinylcholine and Rocuronium.
Main outcome variables
emergence agitation;Myalgia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210714051888N1
Registration date:2021-12-19, 1400/09/28
Registration timing:registered_while_recruiting
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Sepideh Malekpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 1239
Email address
mroozban@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Succinylcholine and Rocuronium effects on the rate of emergence agitation when awakening in patients undergoing direct diagnostic laryngoscopy under general anesthesia
Public title
Succinylcholine and Rocuronium effects on the rate of emergence agitation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 20 to 50 years without a history of disease or with a controlled disease
Exclusion criteria:
The patients with a history of psychiatric illness
The patients with a history of peritonitis
The patients with a history of hyperkalemia
The patients with a history of renal and hepatic failure
The patients with a history of malignant hyperthermia and pseudocholinesterase deficiency
The patients with a history of addiction
The patients with a history of benzodiazepines
The patients with a history of burns
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this clinical trial will be performed by blocking method. Accordingly, 8 blocks will be used, with 6 patients in each block (3 patients in the Saxinylcholine group and 3 patients in the Rocronium group). Randomization is done using random allocation softwares. In addition to simple randomization, these softwares are able to generate random sequences by blocking method. Random allocation concealment is used for hiding Which refers to the method used to execute a random sequence on the participants in the study, so that the assigned group is not known before the individual is assigned. Sequentially numbered opaque envelopes are also used, in which each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelope lids are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient information will be recorded in the data collection sheets by examination by a physician. The patient, the injector, and the person recording the results will be unaware of the type of drug. The person preparing the medicine will be different from the person who injected it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.IUMS.FMD.REC.1399.565
Health conditions studied
1
Description of health condition studied
Diagnostic biopsy under direct laryngoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Agitation
Timepoint
From the moment of closing the gas until 10 minutes after estubation for once
Method of measurement
Emergency agitation of patients from the moment of gas closure until 10 minutes after extubation will be performed according to the criteria of Ricker Sedation Agitation Scale.
2
Description
Myalgia
Timepoint
Myalgia pain scores will be recorded 1, 4, 8 and 24 hours after surgery
Method of measurement
Examination by a Physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: succinylcholine.The first group will receive 3 micrograms / kg of fentanyl and 0.5 mg / kg of lidocaine for premedication, and will be induced with 1 mg / kg of succinylcholine and 5 mg / kg of Nesdonal.The medications used will be common medications available in the operating room
Category
Treatment - Drugs
2
Description
Intervention group 2: Rocronium. The second group will receive 3 micrograms / kg of fentanyl and 0.5 mg / kg of lidocaine for premedication and will be induced with 0.6 mg / kg rocuronium and 5 mg / kg Nesdonal. Second, patients will receive rocuronium instead of succinylcholine.The medications used will be common medications available in the operating room
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Saeid Amniati
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., Sattar Khan St., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
SaeedAmniati@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Kiwani
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه علوم پزشکی ایران
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
Iran University of Medical Sciences
Full name of responsible person
Dr Saeid Amniati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Email
amniati.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeid Amniati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Email
amniati.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sepideh Malekpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
drsepidehmalekpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people are not identified.
When the data will become available and for how long
The data will be available 6 months after the results are published.
To whom data/document is available
Researchers from scientific and academic institutions can apply for the data.
Under which criteria data/document could be used
The data can only be used for scientific research by researchers in scientific and academic centers.
From where data/document is obtainable
Researchers can send their request via email to the project manager.
What processes are involved for a request to access data/document
Applications must be accompanied by a letter of introduction from the institution or university where the researcher is employed. The data will be provided to the researcher no later than two weeks after receiving the request.