Protocol summary

Study aim
Comparison of the effect of intravenous administration of atracurium by preparation method with presleep method with intravenous administration of rocuronium at the optimal time of intubation
Design
Clinical trial, parallel groups, double-blind, randomized, phase 3 on 90 patients. In order to randomize, the block randomization method will be used.
Settings and conduct
Patients who are candidates for general anesthesia at Firouzgar and Rasoul Akram Hospitals in Tehran will be included in the study. Patients will be randomly divided into 3 groups based on blocks of 3. Patients and data analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-emergency surgery, under general anesthesia for more than 120 minutes, Age between 18-50 years, Malampathi 1 and 2, A person with normal health, A person with mild systemic disease. Non-entry criteria: Allergy to the drugs used in the plan, History of asthma, Anxiety, Hemodynamic instability, Addiction, Heart disease, Lung disease, Active cancer, Taking drugs that increase muscle relaxation
Intervention groups
Intervention group 1: In the Prehypnotic group, intravenous midazolam and intravenous fentanyl will be prescribed as a Premedication. The patient will be per oxygenated from the beginning and after 3 minutes, atracurium and 20 seconds after that, Sodium thiopental will be administered intravenously. Intervention group 2: In the Priming group, atracurium will be injected with two Premedication drugs to the patient at the same time. 3 minutes later, sodium thiopental will be administered intravenously, followed by atracurium will be prescribed to the patient in full. Control group: after midazolam and fentanyl, sodium thiopental and immediately rocuronium will be injected intravenously.
Main outcome variables
The time required from the moment of drug injection until the muscles relax

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230518058225N2
Registration date: 2024-03-23, 1403/01/04
Registration timing: prospective

Last update: 2024-03-23, 1403/01/04
Update count: 0
Registration date
2024-03-23, 1403/01/04
Registrant information
Name
Anahita Sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2543
Email address
sadri.anahita@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous administration of atracurium by preparation method with intravenous injection of atracurium with presleep method with intravenous administration of rocuronium at the optimal time of intubation in induction of anesthesia by rapid sequence method using muscle nerve relaxation monitoring
Public title
The effect of intravenous administration of atracurium by the preparation method with intravenous injection of atracurium with presleep method with intravenous administration of rocuronium in the optimal time of intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for non-emergency surgery, under general anesthesia for more than 120 minutes Age between 18-50 years Malampathi 1 and 2 A person with normal health A person with mild systemic disease
Exclusion criteria:
Allergy to the drugs used in the plan History of asthma Anxiety Hemodynamic instability Addiction Heart disease Lung disease Active cancer Taking tetracycline, gentamicin, magnesium and other drugs that aggravate muscle relaxation
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 3 groups. The randomization tool will randomize the table of numbers; The list of random numbers will be received by the researcher from the statistician and the patients included in the study will be divided into three groups. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 9 blocks will be formed and in each block 3 people from intervention group 1, 3 people from intervention group 2 and 3 people will be placed in the control group. A total of 10 blocks will be considered to reach the sample size. Blocks contain numbers, numbers represent study groups. Their order will be determined by the statistician from the beginning. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. became. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware and blind about the type of drug injected. Patients will be aware that they will be randomly assigned to one of the three study groups, but will not know which method will be offered in that group. Patients will be assigned to one of three groups using a random number table. The anesthetist who injects the drug will know the patient category. The person in charge of data collection, the analyst, and the outcome evaluator will collect and analyze the information based on groups 1, 2 and 3, and will not know the type of drug injected in the groups and will be kept blind.
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
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.IUMS.FMD.REC.1401.385

Health conditions studied

1

Description of health condition studied
Intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
The time required from the moment of drug injection until the muscles relax
Timepoint
Continuously from the moment the drug is injected until the muscles relax and the PTC (muscle condition monitoring device) shows zero.
Method of measurement
Measuring with a stopwatch based on seconds

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the Prehypnotic group, At first intravenous midazolam with a concentration of one milligram per cc (with an amount of 40 micrograms per kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company) and intravenous fentanyl with a concentration of 50 micrograms per cc (with The amount of 3 micrograms per kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company) will be prescribed as a Premedication. The patient will be per oxygenated from the beginning and after 3 minutes, atracurium with a concentration of 10 mg per cc (with an amount of 0.75 mg for each kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company) will be completely prescribed and 20 seconds after that, Sodium thiopental (with an amount of 5 mg per kilogram of body weight - Manufacturer: Loghman Pharmaceutical Company) will be administered intravenously immediately. The monitoring of muscle relaxation with the help of the PTC device will continue until the patient is completely relaxed (the PTC device will show zero) and if it becomes zero, intubation will be done immediately.
Category
Treatment - Drugs

2

Description
Intervention group 2: In the Priming group, in addition to intravenous midazolam injection with a concentration of one milligram per cc (with an amount of 40 micrograms per kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company) and intravenous fentanyl with a concentration of 50 micrograms per cc (with Amount of 3 micrograms for each kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company) as a Premedication and atracurium with a concentration of 10 mg per cc (with an amount of 0.05 mg for each kilogram of body weight - company Manufacturer: Aburihan Pharmaceutical Company) will be injected with two drugs to the patient at the same time. 3 minutes later, sodium thiopental (5 mg per kilogram of body weight - manufacturer: Loghman Pharmaceutical Company) will be administered intravenously, followed by atracurium at a concentration of 10 mg per cc (0.75 mg per kilogram of body weight) Body - manufacturer: Aburihan Pharmaceutical Company) will be prescribed to the patient in full. The monitoring of muscle relaxation with the help of the PTC device will continue until the patient is completely relaxed (the PTC device will show zero) and if it becomes zero, intubation will be done immediately.
Category
Treatment - Drugs

3

Description
Control group: After intravenous injection of midazolam with a concentration of 1 mg per cc (with an amount of 40 micrograms for each kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company), fentanyl with a concentration of 50 micrograms per cc (with an amount of 3 micrograms for each kilogram of body weight - manufacturer: Aburihan Pharmaceutical Company), sodium thiopental (with an amount of 5 mg per kilogram of body weight - manufacturer: Laqman Pharmaceutical Company) administered intravenously and immediately rocuronium with a concentration of 10 mg per cc (with The amount of 1.2 mg for each kilogram of body weight - importing company: Darman Yab Daro) will be injected intravenously. The above patients are also monitored by PTC since the administration of rocuronium and the time of Post Tetanic Twitch zero is recorded and the patient will be intubated immediately after zero.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-Akram Hospital
Full name of responsible person
Mohammad Javad Vakili Zarch
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2222
Email
Rasoolhospital@iums.ac.ir

2

Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Mohammad Javad Vakili Zarch
Street address
Beh Afarin Ave, Vali Asr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeed Aghajani
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2533
Email
pooyaderakh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Salehi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modares highway (north), Shahid Vahid Dastgardi street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6247
Email
rsalehi45@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Javad Vakili Zarch
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2222
Email
pezhman.vakili@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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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