Investigating the appropriate dose of sodium thiopental for induction of anesthesia in patients with BMI greater than 25 who undergo surgery with tracheal intubation
Investigating the appropriate dose of sodium thiopental for induction of anesthesia in patients with BMI greater than 25 with BIS monitoring who undergo general surgery
Design
Clinical trial, with three parallel groups, single-blinded, randomized and including 90 patients. The rand function of Excel software is used for randomization.
Settings and conduct
To induce general anesthesia in patients, three different formulas are used based on weight, and the depth of anesthesia and vital signs are measured. The patients are all candidates for elective surgery, and the study is performed in the operating room of Mehdi Clinic, Imam Khomeini Hospital. Patients do not know which group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Age 20 to 60 years
2- ASA CLASS 1&2
3- ASA CLASS 3 if it is due to BMI more than 40
4- Obtaining informed consent to participate in the project
5- BMI>25
Intervention groups
Patients were divided into three groups based on the method of calculating the initial dose of sodium thiopental. Three groups include:
1- Initial dose based on total body weight
2- Initial dose based on ideal body weight with the following calculation formula:
(Male: Ideal Body Weight (kg) = 50 kg + 2.3 kg per inch (2.54 cm) over 5 feet (152 cm.
Female: Ideal Body Weight (kg) = 45.5 kg + 2.3 kg per inch over 5 feet)
3- Initial dose based on adjusted body mass with the following calculation formula:
Adjusted body mass = Ideal body weight + 0.4 (Total body mass – ideal body weight
Main outcome variables
Depth of anesthesia; heart rate; mean arterial pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230825059254N1
Registration date:2023-09-30, 1402/07/08
Registration timing:prospective
Last update:2023-09-30, 1402/07/08
Update count:0
Registration date
2023-09-30, 1402/07/08
Registrant information
Name
Amirhossein Farhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 1782
Email address
am.farhady@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the appropriate dose of sodium thiopental for induction of anesthesia in patients with BMI greater than 25 who undergo surgery with tracheal intubation
Public title
Investigating the appropriate dose of sodium thiopental for induction of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class I and II
ASA Class III if it is due to BMI more than 40
BMI more than 25
obtaining informed consent
Exclusion criteria:
Patients with age less than 20 years or more than 60 years
Discontentment with the project
ASA Class IV and V
Patients with unstable hemodynamics, hemorrhagic shock and heart failure
Recent abuse of morphine or any other drugs
Patients with porphyria, asthma, uncontrolled hypertension and hypothyroidism
Patients with lowering of consciousness
Patients with drug allergies
Patients requiring second laryngoscopy or failed intubation
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the existence of three groups of thirty members in the study, 6 blocks of three were created:
1. ABC
2. ACB
3. BAC
4. BCA
5. CAB
6. CBA
A: Sodium thiopental is injected to the patient based on total body weight.
B: Based on ideal body weight, sodium thiopental is injected to the patient.
C: Based on adjusted body mass, sodium thiopental is injected to the patient.
Using Excel software, a random number between 0 and 9 is created. The block corresponding to each number indicates on what basis each patient receives sodium thiopental. To reach a sample size of 90 (30 people in each group), this work is repeated 30 times. Random numbers zero, 7, 8 and 9 are ignored.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were unaware of which study group they were in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.174
Health conditions studied
1
Description of health condition studied
Appropriate dose of sodium thiopental for induction of anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bispectral Index
Timepoint
Before induction of anesthesia, after injection of sodium thiopental, three minutes after induction of anesthesia
Method of measurement
BIS monitoring
Secondary outcomes
1
Description
Heart Rate
Timepoint
Before induction of anesthesia, after injection of sodium thiopental, three minutes after induction of anesthesia
Method of measurement
Pulse oximetry
2
Description
Mean Arterial pressure
Timepoint
Before induction of anesthesia, after injection of sodium thiopental, three minutes after induction of anesthesia
Method of measurement
NIBP monitoring
Intervention groups
1
Description
Intervention group: In the first intervention group, sodium thiopental was calculated and injected based on total body weight to induce anesthesia.
Category
Other
2
Description
Intervention group: In the second intervention group, sodium thiopental was calculated and injected based on ideal body weight to induce anesthesia.
Category
Other
3
Description
Intervention group: In the third intervention group, sodium thiopental was calculated and injected based on adjusted body mass to induce anesthesia.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Amirhossein Farhadi
Street address
End of Keshavarz blvd, Tehran
City
Tehran
Province
Tehran
Postal code
14197333141
Phone
+98 21 6119
Email
imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
6th floor, Central University Organization, Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?