Republic of Iraq

Ministry of Health

Approval form of a Research Protocol/ Ministry of Health (Form number 02/2021)

)02/2021 ‫استمارة املوافقة على مشروع بحث في وزارة الصحة(استمارة رقم‬

● This form should be filled in electronically (Manually filled in form will not be accepted) by the researcher and submitted manually to
the research unit at the relevant Health Directorate to be displayed at its Research committee. No research is allowed to be conducted
at the institutions of Ministry of Health without having in advance the committee’s approval.
● This form can be downloaded from the official website of Ministry of Health/ Iraq: https://moh.gov.iq

1. PERSONAL INFORMATION

1.1 Principal Investigator

Name Specialty Place of work Phone number E mail

Msc ansthesia and ICU

Mohammed abdalzahra AL _ sader hospital 07718991533 smralmmry@gmail.com
techniques

1.2 Other investigators

Name Specialty Place of work Phone number E mail

Ansthesia and ICU University of AL_Forat

Ridha Nadher Talle techniches. AL_Awsat Techniechs
07730353466 Ridhaboss.n@gmail.com

Ansthesia and ICU University of AL_Forat ahmed.wahab.ckm171@student.atu.

Ahmed hazem abd alwahab +9647844683233
techniches.. AL_Awsat Techniechs. edu.iq

Ansthesia and ICU University of AL_Forat hassan.mdalloul.chm32@student.atu.

Hussin hamed madlol 07804856239
techniches.. AL_Awsat Techniechs edu.iq

Ansthesia and ICU University of AL_Forat

Mohammed lafta fleiah 07833116245 muhameed9143@gmail.com
techniches. AL_Awsat Techniechs

2. RESEARCHINFORMATION

2.1 Is the research title from the Ministry of Health’s list of priorities: 2.1: The list is issued every year
and found on MoH website.
√ Yes ☐No
2.2 The purpose of doing the research:Choose an item.

If the answer is others, please, specify: Click or tap here to enter text.

3. RESEARCHTOPIC

3.1 The Research Title: 3.1: Write down the title of your
research.
Effect of different analgesic dose of ketamine on hemodynamic stability in
old age patient under spinal ansthesia
1 | Page
3.2 The Research Question:
3.2: Write down the smart
Is ketamine have effect on hymodynamic stability in old age patient under spinal ansthesia research question.

3.3Research Background (with references in Vancouver style): 3.3: Write concisely the scientific
bases of your research question.
Click or tap here toGlobally, the population is aging, and an estimated 10% of Use updated and new references.
the population undergoing procedures and surgery areaged 75 years or older. In
the USA, this population ispredicted to rise to 19% of the population by 2030
Regional anesthesia is increasingly relevant in the feldof anesthesia, and is an
important tool for pain management in the elderly population. Regional anesthesia
refersto the use of local anesthetic agents to decrease painfulsensory input from
surgical sites to the brain. By decreasing the amount of nociceptive signal
transmitted to thecentral nervous system (CNS), fewer centrally acting medications
such as opiates or systemic anesthetic agents arenecessary during and after surgery
Due to the physiologicprocess of aging, the elderly are particularly susceptible to
the efects of these medications. Compounding the vulnerability of this population
are the cardiopulmonary disease,hepatic dysfunction, and renal impairment so
often seenwith aging(Lin, C et al 2019)

intravenous ketamine has been used as an analgesic adjuvant in a variety of

chronic pain syndromes for years, and the analgesic effect is primarily based on the
antagonism of NMDA receptors.(Yeh, P. S et al 2011)

ketamine has been mostly used for anesthesia, analgesia, sedation and treatment
of chronic pain syndromes. However, unique pharmacodynamic properties of
ketamine have increased interests in it's use for treatment of depression ,Acute
side effects, such as increased salivation, increase in heart rate, systemic arterial
pressure and intracranial pressure necessitate careful monitoring during
intravenous administration of ketamine, even in subanesthetic doses. However,
major burden of ketamine administration lies in it's ability to produce
psychotomimetic side effects and emergence delirium(Mihaljević, S. et al 2020)

1-Lin, C., Darling, C., &Tsui, B. C. (2019). Practical regional anesthesia guide for
elderly patients. Drugs & Aging, 36, 213-234.

2-Yeh, P. S., Shen, H. N., & Chen, T. Y. (2011). Oral ketamine controlled
refractory nonconvulsive status epilepticus in an elderly patient. Seizure, 20(9), 723-
726.

3-Mihaljević, S., Pavlović, M., Reiner, K., &Ćaćić, M. (2020). Therapeutic

mechanisms of ketamine. PsychiatriaDanubina, 32(3-4), 325-333. enter text.

3.4Justification of Choosing this topic (Rationale): 3.4: Show the rationale of

choosing this research question
To maintain hemodynamic variables in old age patients under spinal ansthesia
and what are the expected gab
3.5 The Objective/s of the Research: that this research is going to fill.

To compare different doses of ketamine 3.4: Write down primary and

secondary objectives

2 | Page
4. Research Setting

4.1 When will the sample be collected?

Start1 February 2024 End1 april 2024

4.2 Where will the study be implemented?

Name of Institution Name of authorized person Signature Date and stamp

1 Al_ hakeem hospital

2 Al_najaf AL_Ashref hospital

3 AL_ Saader hospital

4 AL_Mishkhab hospital

5 Click or tap here to enter text.

4.3 The resources needed from the institution selected to implement the research?

The resource needed tick Amount and types

Laboratory sample (Blood, urine, ….) ☐ Click or tap here to enter text.

Devices, instrument, tools …… ☐ Click or tap here to enter text.

Patients’ or firm’s records √ Click or tap here to enter text.

Persons (patients, employers) ☐ Click or tap here to enter text.

Others specified √ Click or tap here to enter text.

4.4 Who will fund the research?Choose an item.

If the answer is others, please, specify:

Mohammed abd al zahra

5. RESEARCH METHODOLOGY
5.1: write the design of the study
5.1Study Design:choose one from below that is going to answer your
research question
Choose an item.

If the answer is others, please, specify: Click or tap here to enter text. 5.2: It is the operational definition
used to enroll participants in the
5.2 Case Definition: study

Click or tap here to enter text.

5.3: the participants that fulfil
5.3 Exclusion Criteria: case definition, but excluded from
the study due to a specific cause

3 | Page
5.4: the method used to select
the participants of the sample
from the targeted sample.
 Click or tap here to enter text.

5.4 Sampling Methods:

Click or tap here to enter text.

5.5 Randomization and Blinding Methods (If relevant): 5.5: Write details about how to
allocate participants in study
Prospective randomized control trial arms or blinding them if the study
design is relevant
5.6 Selection of Participants in control group (If Relevant):
5.6: Criteria of enrolling
Click or tap here to enter text. participants in the control group

5.7 Definition of Outcomes and how to measure it: 5.7: Variables used to answer the
research question. Write them in
Click or tap here to enter text. details; how do you measure
them, when and by whom.
5.8 The Procedure (steps) of the Study:
5.8: Steps of performing the
Click or tap here to enter text. study.

5.9 Statistical Analysis and sample size: 5.9: define types of variables.
What are the statistical tools used
Click or tap here to enter text. to measure p value? How are you
going to show your results? … etc

6. ETHICAL CONSIDERATION 6: Write down the type of

consent and provide a copy of it.
Will be taken from AL_ Najaf health director and AL_ Furat AL_Awsat University Show how you abide by the terms
of Code of ethics in research.

7. ATTACHED DOCUMENTS (Tick the appropriate box)

√ Participants’ Consent Form ☐ Questionnaire & Data Retrieving √ University letter
form (Student)

☐ Professional ID √ Others: Click or tap here to enter text.

8. SIGNING A PLEDGE
We, the undersigned researcher/ researchers, pledge to:

1. Implement the research project as described in this version, and that we do not perform any changes or
modifications, after it was approved by the research committee, only with the written agreement of the
Research Committee in the Health Directorate that approved the mentioned project.
2. That the preliminary approval was obtained from (Click or tap here to enter text.) to undertake research in
the aforementioned hospital and to take advantage from the facilities it provides to the researcher based
on what is mentioned in this project, and we herein certify the validity of the signature and stamp set out
paragraph (2-4).

4 | Page
 3. That we will abide by all orders, instructions and regulatory directives issued by the management of the
health institution in which the research will be implemented.
4. That we will maintain all the property of the health institution, including premises, devices, machines, tools,
material and documents, and not to misuse it physically or morally, not to impede or disrupt the daily work
of the institution as well while we are inside it to accomplish the research.
5. To obtain only what we are entitled to by the approval decision in order to conduct research based on the
preliminary approval of the health institution in which the research will be conducted.
6. That we have read the Code of Ethics in Researchapproved by the Ministry of Health and that we will
adhere to its entire provisions in all stages of implementing the research and that it is seen as
complementary to the decision of the Research Committee.
7. That we will brief the health institution on the research results for the purpose of taking advantage of them.

Principal researcher's name, signature, date: Mohammed abd Alzahra.

Researcher's name, signature, date Ridha Nadher Talle.

Researcher's name, signature, date: Ahmed hazem abd alwahab

Researcher's name, signature, date: Hussain hamed madlol

Researcher's name, signature, date :tamara sahib rassol

Researcher's name, signature, date: rehab khadhem mohammed

Researcher's name, signature, date: ruqayia najih kalaf

Researcher's name, signature, date: Zahra haider hussain

Researcher's name, signature, date: zaineb ali abd alhussain

Researcher's name, signature, date: zainab nieema radhi

Researcher's name, signature, date: shahad sajad majhol

Researcher's name, signature, date: Fatima bassim kareem

Researcher's name, signature, date: Fatima jasim shamich

Researcher's name, signature, date: Fatima safaa abd almahdi

Researcher's name, signature, date: Kawther raad hamodi

Researcher's name, signature, date: luma hani khadhem

Researcher's name, signature, date: mohammed lafta fleeh

Researcher's name, signature, date: nor alhuda ali hussain

Researcher's name, signature, date: zahraa jaffer sadiq

Researcher's name, signature, date: nabaa sameer kareem

Researcher's name, signature, date: hiba riadh kamel

5 | Page
Researcher's name, signature, date: mariam jowad kmal

6 | Page