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Comparison of the Effect of Oral Melatonin, Vitamin C and Clonidine on the Hemodynamic Response to Endotracheal Intubation, Anesthetic Requirements and Pain after Septorhinoplasty

Protocol summary

Study aim
Comparison of the effect of melatonin, vitamin C and oral clonidine on hemodynamic response
Design
A double-blind, randomized, phase 0 clinical trial study on 120 patients, randomization using a computer-generated random number table.
Settings and conduct
The current study is a randomized study conducted in the general operating room of Imam Khomeini Teaching Hospital in Ahvaz, the research community in this study includes patients who are candidates for septorhinoplasty surgery, general anesthesia and endotracheal intubation, the patients are randomly assigned to three groups of melatonin (group M ), vitamin C (group C) and clonidine (group Cl) will be divided and allocation concealment will be done using sealed opaque envelopes.
Participants/Inclusion and exclusion criteria
Age group 18-40 years old, physical condition I-II of the American Society of Anesthesiology, candidate for general anesthesia and endotracheal intubation, physical condition III or above of the American Society of Anesthesiology, mental illness, alcohol abuse, physical problem (heart, liver, kidney, allergic)
Intervention groups
One day before surgery, all patients will undergo a detailed evaluation of preoperative anesthesia and will be kept fasting for eight hours according to the ASA standard protocol. Each group of patients will receive two tablets 120 minutes before induction of anesthesia. All patients 1 They will receive milligrams of midazolam as a pre-medication. The pain level of all patients will be recorded based on a 10-point VAS scale.
Main outcome variables
Monitoring changes in hemodynamic response to laryngoscopy and endotracheal intubation after receiving oral melatonin, vitamin C, and clonidine, the amount of need for anesthetic drugs, the amount of pain in patients after septorhinoplasty in PACU based on a 10-point VAS scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210222050463N2
Registration date: 2023-06-26, 1402/04/05
Registration timing: prospective

Last update: 2023-06-26, 1402/04/05
Update count: 0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Noushin Sarvi Sarmeidani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3390 6395
Email address
sarvi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
2023-08-23, 1402/06/01
Actual recruitment end date
2023-08-23, 1402/06/01
Trial completion date
2023-11-22, 1402/09/01
Scientific title
Comparison of the Effect of Oral Melatonin, Vitamin C and Clonidine on the Hemodynamic Response to Endotracheal Intubation, Anesthetic Requirements and Pain after Septorhinoplasty
Public title
Comparison of the effects of melatonin, vitamin C and oral clonidine on the patient's hemodynamic response during anesthesia and afterwards to pain in septorhinoplasty surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age group is 18-40 years Physical status I-II American Society of Anesthesiology Candidate for general anesthesia and endotracheal intubationCommunity Verified icon
Exclusion criteria:
Physical status III and above American Society of Anesthesiology History of cognitive and mental disorders (dementia, severe depression)Community Verified icon Patients who take anti-anxiety, sedative, anti-psychotic or anti-epileptic drugs. History of circadian rhythm disorders such as chronic fatigue syndrome and sleepiness History of chronic pain syndromes Body mass index more than 30 kg/m² History of difficult airway (Cormack Lehan grade [1] 2 or higher) or more than one intubation attemptCommunity Verified icon History of obstructive sleep apnea and severe asthmaCommunity Verified icon History of drug or alcohol abuse History of congestive heart failure, heart block or bradycardia History of liver or kidney failure History of allergic reaction to studied drugsCommunity Verified icon Patients who have difficulty communicating.Community Verified icon If the patient moves during laryngoscopy or intubation.Community Verified icon
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
. Using a table of random numbers generated by the computer, eligible patients will be randomly divided into three groups: melatonin (M group), vitamin C (C group) and clonidine (Cl group) and allocation concealment using envelopes. sealed matte will be done. Both the patient and the researcher will be unaware of the type of drug. The patients in the melatonin group received two tablets (3 mg each), the patients in the vitamin C group received two tablets (1 g each), and the patients in the clonidine group also received two tablets (0.1 mg each) 120 minutes before induction of anesthesia. will do The study drugs in all three groups will be the same in terms of size and color and will be given to the patient by the nursing staff in the ward.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6143975617
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.AJUMS.REC.1402.091

Health conditions studied

1

Description of health condition studied
Determining the effect of oral melatonin, vitamin C and clonidine on the hemodynamic response to laryngoscopy and endotracheal intubation, the need for anesthetics and pain after septorhinoplasty.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determining the effect of melatonin, vitamin C and oral clonidine on hemodynamic response
Timepoint
Continuously at baseline (T0), 120 minutes after study drug administration, upon entering the operating room (T1), after induction of anesthesia (T2), just before laryngoscopy and endotracheal intubation (T3), after Intubation at intervals of 1 minute (T4), 3 minutes (T5), 5 minutes (T6), 10 minutes (T7) and 15 minutes (T8)
Method of measurement
Operating room monitoring device

Secondary outcomes

1

Description
Reducing the use of anesthetics and postoperative painCommunity Verified icon
Timepoint
During and after the operation
Method of measurement
VAS

Intervention groups

1

Description
Intervention group:
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
General operating room of Imam Khomeini Teaching Hospital, Ahvaz
Full name of responsible person
ali khalafi
Street address
Ahwaz Jundishapur University
City
ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Biranvand
Street address
Ahwaz University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research committee of Ahvaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Sarvi Sarmeidani
Position
faculty (master's degree)
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Ahwaz University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Sarvi Sarmeidani
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Ahwaz University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Sarvi Sarmeidani
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Ahwaz University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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