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Comparison of melatonin and midazolam on preoperative anxiety and intraoperative hemodynamic disorders in patients candidates for cataract surgery

Protocol summary

Study aim
Comparison of Melatonin and Midazolam on preoperative anxiety and intraoperative hemodynamic disorders in patients candidates for cataract surgery.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. The block method will be used for randomization.
Settings and conduct
This study is conducted in Razi Birjand Hospital, South Khorasan Province, Iran. 40 patients are randomly divided into two intervention groups (A-B). Questions related to preoperative spray anxiety will be asked and evaluated by the study administrator.
Participants/Inclusion and exclusion criteria
Our study population is patients who are candidates for cataract surgery, referring to the eye surgery department of Razi Hospital in Birjand city in 2022, who will be operated under general anesthesia. Inclusion criteria will include informed consent, ASA class 1 and 2. Exclusion criteria: drug addiction; lack of cooperation with the study manager; heart failure; uncontrolled blood pressure; use of anticoagulants; use of anti-epileptic drugs; use of immunosuppressive drugs; history of liver or kidney diseases; confusion, dementia, lack of verbal communication, chronic use of narcotics, treatment with barbiturates or antipsychotic drugs; allergies; body mass index below 18.5 or above 30.
Intervention groups
The studied patients, candidates for cataract surgery, who were randomly assigned to one of two groups: the first group receiving melatonin (0.1 mg/kg of melatonin tablets manufactured by ASI Italy) one hour before the operation, the second group receiving midazolam (70-80 micrograms/kg intravenous manufactured by Elixir Pharmaceutical Company) will be given one hour before the operation.
Main outcome variables
Anxiety; hemodynamics of the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N15
Registration date: 2022-11-01, 1401/08/10
Registration timing: prospective

Last update: 2022-11-01, 1401/08/10
Update count: 0
Registration date
2022-11-01, 1401/08/10
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of melatonin and midazolam on preoperative anxiety and intraoperative hemodynamic disorders in patients candidates for cataract surgery
Public title
Comparison of melatonin and midazolam on preoperative anxiety and intraoperative hemodynamic disorders in cataract surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to enter the study ASA class 1 and 2
Exclusion criteria:
Having a drug addiction Failure to cooperate with the study manager Heart failure Uncontrolled blood pressure Anticoagulant use Taking anti-epileptic drugs Taking immunosuppressive drugs History of liver or kidney diseases Confucius Dementia Lack of verbal communication Chronic use of narcotics Treatment with barbiturates or antipsychotic drugs Allergy Body mass index below 18.5 or above 30
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
The placement of people in each group is randomly placed in one of two groups: the first group receiving melatonin (0.1 mg/kg of melatonin tablets manufactured by ESI Italy) (A) one hour before the operation, the second group receiving midazolam (Dose of 80-70 micrograms/kg intravenous manufactured by Elixir Pharmaceutical Company) (B) will also be given one hour before surgery. One of these blocks will be randomly selected and the patients will be divided into one of Two groups A, B. Then randomization will be done for other patients as well.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome Evaluator: The study facilitator (medical student) will perform the necessary evaluation without knowing the type of medication received by the patients and will be recorded in a checklist designed for this purpose. Patients: The patients participating in the study are not aware of their group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2022-01-18, 1400/10/28
Ethics committee reference number
IR.BUMS.REC.1400.324

Health conditions studied

1

Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract

Primary outcomes

1

Description
Anxiety
Timepoint
The patient's anxiety will be evaluated before the administration of the medicine in the eye department (2 hours before the operation), before the surgery and before entering the operating room and in the waiting room for the operation in a conscious state (half an hour before the operation) using Beck's anxiety questionnaire.
Method of measurement
Beck Anxiety Questionnaire

2

Description
Hemodynamics of the patient
Timepoint
Hemodynamics of the patients before the operation (2 hours before the operation), during (half an hour after the start of the operation in the operating room) and after the surgery (after the patient is fully awake, 6 hours after the operation) are investigated by the researcher.
Method of measurement
Hemodynamics of patients, including blood pressure before (2 hours before the operation) and after the operation (after the patient is fully awake, 6 hours after the operation) in the ward using a sphygmomanometer and a medical phone by the study manager (medical intern) and counting Heart rate will be obtained using the radial pulse. Also, the monitoring device in the operating room will be used to check the hemodynamics during the operation (half an hour after the start of the operation in the operating room).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group 1 patients will receive melatonin (0.1 mg/kg melatonin tablets manufactured by ASI Italy) one hour before the operation.
Category
Treatment - Drugs

2

Description
Intervention group 2: patients who are candidates for cataract surgery, will receive midazolam (70-80 micrograms/kg IV manufactured by Elixir Pharmaceutical Company) one hour before the operation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Otorhinolaryngology Clinic, Razi Birjand Hospital
Full name of responsible person
Atefe Sherbaf Yazdi
Street address
Otorhinolaryngology Clinic of Rzai Hospital , Ghafari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6000
Fax
Email
razihospital@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Miri
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Malihe Zangoee
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1500
Email
mzangoue@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish individual patient information
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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