Comparison of two drugs, dexamethasone and hydrocortisone, on the hemodynamic responses of tonsillectomy patients in Bandarabass Payambar Azam Complex in 2024-2025.
Investigating the effect of two drugs, Dexamethasone and Hydrocortisone, on the hemodynamic responses of tonsillectomy patients.
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 238 patients. Random double-blind method according to the random allocation table.
Settings and conduct
The study is conducted in Bandar Abbas Shahid Mohammadi Hospital. Patients are randomly assigned to two equal groups of dexamethasone or hydrocortisone. Patients in the first group receive an intravenous dose of 0.5 mg/kg of dexamethasone, and patients in the second group receive an intravenous dose of hydrocortisone of 1 mg/kg. These drugs are similar in appearance, and the patient and the person injecting, as well as the person collecting the data, are not aware of the contents of the bottle. Induction of anesthesia is performed using a standard protocol.
Participants/Inclusion and exclusion criteria
All patients who refer to Bandar Abbas Shahid Mohammadi Hospital for tonsillectomy.
Intervention groups
Patients are randomly assigned to two equal groups of dexamethasone or hydrocortisone. Patients in the first group receive an intravenous dose of 0.5 mg/kg of Dexamethasone, and patients in the second group receive an intravenous dose of Hydrocortisone of 1 mg/kg. These drugs are prescribed before induction of anesthesia. Induction of anesthesia is performed using a standard protocol. Heart rate and blood pressure are continuously monitored and recorded.
Main outcome variables
Blood pressure; Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240304061162N1
Registration date:2024-03-18, 1402/12/28
Registration timing:prospective
Last update:2024-03-18, 1402/12/28
Update count:0
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Mohammad Matin Yadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3641 9256
Email address
matin.yadollahi78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two drugs, dexamethasone and hydrocortisone, on the hemodynamic responses of tonsillectomy patients in Bandarabass Payambar Azam Complex in 2024-2025.
Public title
Comparison of the effect of Dexamethasone and Hydrocortisone on hemodynamics
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who refer to Bandar Abbas Shahid Mohammadi Hospital for tonsillectomy.
Exclusion criteria:
Patients who have allergies or contraindications to dexamethasone or hydrocortisone drugs.
Patients taking medications that may interfere with medications or hemodynamic responses.
Underlying diseases: conditions such as heart disease, hypertension, or any other condition that can affect hemodynamic responses.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
236
Randomization (investigator's opinion)
Randomized
Randomization description
By using a random allocation table, we eliminate biases and ensure that any observed differences can be attributed solely to the treatment.
Creation of the Table: A random allocation table is generated in advance. It contains a list of unique participant identifiers (e.g., patient numbers) and corresponding treatment assignments (either Dexamethasone or Hydrocortisone).
Assignment Process: When a participant enters the study, their identifier is matched with the next available treatment assignment from the table. The allocation is completely unpredictable, ensuring fairness.
Concealing Group Assignments: Participants are unaware of their group assignment until the study concludes. Those administering the treatment (researchers, nurses, etc.) are also blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug Bottles: The Dexamethasone and Hydrocortisone bottles will be identical in appearance. Neither the patient nor the person injecting will be aware of the contents of the bottle.
Participants’ Blinding: the patients do not know whether they are receiving Dexamethasone or Hydrocortisone.
Researchers’ Blinding: The anesthetist who administers the intravenous dose will not know whether it’s Dexamethasone or Hydrocortisone.
Data Collectors' Blinding: The data collector recording vital signs will remain unaware of the drug contents. Also, the data collector of postoperative complications does not know what drugs the patients received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Educational Complex of University of Medical Sciences, the beginning of Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2025-02-05, 1403/11/17
Ethics committee reference number
IR.HUMS.REC.1402.429
Health conditions studied
1
Description of health condition studied
Complications of tonsillectomy surgery
ICD-10 code
T81.9XXA
ICD-10 code description
Unspecified complication of procedure, initial encounter
Primary outcomes
1
Description
Change in blood pressure
Timepoint
Blood pressure measurement before intubation, 1 minute, 3 minutes and 5 minutes after intubation and every 5 minutes after that.
Method of measurement
Digital blood pressure gauge
2
Description
Changes in heart rate
Timepoint
Heart rate measurement before intubation, 1 minute, 3 minutes and 5 minutes after intubation and every 5 minutes after that.
Method of measurement
Heart rate monitor
Secondary outcomes
1
Description
Cough
Timepoint
As long as the patient is in the recovery room.
Method of measurement
Observing the presence or absence of cough
2
Description
Chills
Timepoint
As long as the patient is in the recovery room.
Method of measurement
Observing the presence or absence of chills.
3
Description
Nausea
Timepoint
As long as the patient is in the recovery room.
Method of measurement
Observing the presence or absence of nausea.
4
Description
Vomit
Timepoint
As long as the patient is in the recovery room.
Method of measurement
Observing the presence or absence of Vomit.
5
Description
Laryngeal spasm
Timepoint
During tracheal tube removal.
Method of measurement
Observing the presence or absence of Laryngeal spasm.
Intervention groups
1
Description
Intervention group: Patients in the dexamethasone group receive an intravenous dose of 0.5 mg/kg of dexamethasone. This drug is prescribed before induction of anesthesia. Induction of anesthesia is performed using a standard protocol. Midazolam 0.5 mg/kg intravenously for sedation, fentanyl 1-3 μg/kg intravenously for analgesia, propofol 2 mg/kg intravenously for induction of anesthesia and atracurium 0.5 mg/kg intravenously is prescribed to facilitate intubation. Intubation is done using a suitable tracheal tube based on the age and size of the patient. The tube is inserted into the trachea and fixed. Continuous monitoring of heart rate and blood pressure before induction of anesthesia, before intubation, 1 minute, 3 minutes and 5 minutes after intubation and after that every 5 minutes is done and recorded. Also, the symptoms of cough, shivering, nausea and vomiting in the recovery room and larynx spasm during tracheal tube removal are recorded.
Category
Rehabilitation
2
Description
Intervention group: Patients in the hydrocortisone group receive an intravenous dose of hydrocortisone of 1 mg/kg. This drug is prescribed before induction of anesthesia. Induction of anesthesia is performed using a standard protocol. Midazolam 0.5 mg/kg intravenously for sedation, fentanyl 1-3 μg/kg intravenously for analgesia, propofol 2 mg/kg intravenously for induction of anesthesia and atracurium 0.5 mg/kg intravenously is prescribed to facilitate intubation. Intubation is done using a suitable tracheal tube based on the age and size of the patient. The tube is inserted into the trachea and fixed. Continuous monitoring of heart rate and blood pressure before induction of anesthesia, before intubation, 1 minute, 3 minutes and 5 minutes after intubation and after that every 5 minutes is done and recorded. Also, the symptoms of cough, shivering, nausea and vomiting in the recovery room and larynx spasm during tracheal tube removal are recorded.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Payambar Azam Educational and therapeutic complex
Full name of responsible person
Dr. Pejman Shahrokhi
Street address
Jomhoori Eslami Blvd., Payambar Azam Educational and therapeutic complex
City
Bandar Abass
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3347 0001
Email
info@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Vali Alipour
Street address
Imam Hossein Blvd.
City
Bandar Abass
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
v.alipour53@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Matin Yadollahi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bandar Abbas University of Medical Sciences, Imam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 71 3641 9256
Fax
Email
matin.yadollahi78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid vatankhah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Payambar Azam educational and therapeutic complex, Jomhoori Eslami Blvd.
City
Bandar Abass
Province
Hormozgan
Postal code
7919915519
Phone
00980763347000
Email
matin.yadollahi78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Matin Yadollahi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bandar Abbas University of Medical Sciences, Imam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 71 3641 9256
Fax
Email
matin.yadollahi78@gmail.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