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Comparison of two oral precursors of melatonin and gabapentin in female candidates for cesarean section under spinal anesthesia

Protocol summary

Study aim
Comparison of pain and anxiety levels in the placebo group, the melatonin receptor group and the gabapentin reciptor group
Design
Clinical trials with control group, with parallel, double-blind, and randomized groups
Settings and conduct
The patients were randomly allocated to three groups as follows : one group received melatonin , one group received gabapentin and one group received placebo, and the degree of postoperative pain and restlessness measured in Ayatollah Taleghani hospital in Arak.
Participants/Inclusion and exclusion criteria
full-term pregnant women aged 18 to 40 years old undergoing elective cesarean section under spinal anesthesia contraindications for gabapentin or melatonin failed or partial spinal anesthesia gravidity more than 3 Intrauterine Growth Restriction fetal distress history of alcoholism, drug abuse ,convulsion, migraine, dicopathy ,hepatitis ,renal failure ,cardiovascular or pulmonary diseases ,preeclampsia or eclampsia, hypertension, diabete
Intervention groups
30 minutes before spinal anesthesia in a group 300 mg of gabapentin and in another group, 3 ml of melatonin is given orally and given to a group placebo. All patients are given 5 ml / kg of serum ringer before spinal anesthesia.
Main outcome variables
Pain and anxiety score,the amount of the drug

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190120042432N1
Registration date: 2019-07-21, 1398/04/30
Registration timing: prospective

Last update: 2019-07-21, 1398/04/30
Update count: 0
Registration date
2019-07-21, 1398/04/30
Registrant information
Name
samira davodabadi farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 5514
Email address
setaresetare004@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two oral precursors of melatonin and gabapentin in female candidates for cesarean section under spinal anesthesia
Public title
Comparison of two oral precursors of melatonin and gabapentin in female candidates for cesarean section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
full-term pregnant women aged 18 to 40 years old undergoing elective cesarean section under spinal anesthesia
Exclusion criteria:
contraindications for gabapentin or melatonin failed or partial spinal anesthesia gravidity more than 3 Intrauterine Growth Restriction fetal distress history of alcoholism, drug abuse ,convulsion, migraine, dicopathy ,hepatitis ,renal failure ,cardiovascular or pulmonary diseases ,preeclampsia or eclampsia, hypertension, diabete
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
یفتفلPatients were randomized according to the charts which was derived from www.randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
pregnant woman undergoing cesarean section and investigators were blinded to the study treatments.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of medical sciences, Pardis site,Sardasht
City
Arak
Province
Markazi
Postal code
3951616558
Approval date
2018-01-24, 1396/11/04
Ethics committee reference number
IR.ARAKMU.REC.1396.297

Health conditions studied

1

Description of health condition studied
Evaluation of pain and anxiety in female candidates for cesarean section under spinal anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The rate of anxiety and postoperative pain
Timepoint
Based on the Verbal Anxiety Scale, anxiety and pain levels is measure before premedication, before spinal anesthesia, five minutes after spinal anesthesia, after exiting the infant, and 15 minutes after spinal anesthesia as well as after surgery and patient transmission to recovery.
Method of measurement
With using the Verbal Anxiety Scale

Secondary outcomes

1

Description
The amount of the analgesic drug
Timepoint
Within 12 hours after surgery
Method of measurement
5 cc syringe using for drug injection

Intervention groups

1

Description
31persons receive 300 mg oral gabapentin, 30 minutes before the onset of spinal anesthesia.
Category
Treatment - Drugs

2

Description
31persons receive 3 mg oral melatonin, 30 minutes before the onset of spinal anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital of Ayatollah Taleghani, Arak
Full name of responsible person
Yazdi Bijan
Street address
Ayatollah Taleghani Hospital, Imam Khomeini Blvd.,Valiasr Square
City
Arak
Province
Markazi
Postal code
3951611659
Phone
+98 86 3222 5514
Email
setaresetare004@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yazdi Bijan
Street address
Arak University Of Medical Sciences, Pardis Site, Sardasht
City
Arak
Province
Markazi
Postal code
3651616558
Phone
+98 86 3417 3506
Email
yazdi.b@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Yazdi Bijan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Arak University of medical sciences,Pardis Site,Sardasht
City
Arak
Province
Markazi
Postal code
3951616558
Phone
+98 86 3417 3506
Email
yazdi.b@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yazdi Bijan
Position
Assosiate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Arak University of medical sciences,Pardis Site,Sardasht
City
Arak
Province
Markazi
Postal code
3951616558
Phone
+98 86 3417 3506
Email
yazdi.b@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yazdi Bijan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Arak University of medical sciences,Pardis Site,Sardasht
City
Arak
Province
Markazi
Postal code
3951616558
Phone
+98 86 3417 3506
Email
yazdi.b@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All agreed items for publication, such as shared data, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in the database, and data classification system after unidentifiable individuals and maintaining of privacy are publishable.
When the data will become available and for how long
The beginning of the access period one year after the publication of the results
To whom data/document is available
Only scholars working in academia
Under which criteria data/document could be used
In order to use in other studies and scientifics work and obtain information for the preparation of the article
From where data/document is obtainable
Daudabadi Farahani Samira To email address setaresetare004@gmail.com
What processes are involved for a request to access data/document
No need for a specific process and sent by email.
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