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Assessment on the effect of Melatonin on Pain control after Abdominal Hystrectomy

Protocol summary

Summary
As the human studies on the effect of Melatonin” as an adjuvant drug” has been restricted, and contradictory. And it has been known pain perception is multifactoria, we decided to compare the effect of preventive doses of Melatonin and Pregabalin in patients who will be candidated for abdominal hysterectomy under general anesthesia. The study will be a randomized double blinded clinical trial. After taking the confirmation from research and ethical committee of Guilan University , and consent inform from patients, 20 cases in ASA I, II , between 35-55 years old will be put into the study. The day before the TAH, patients educated by one of the members about method of study and drug administration and adverse effects. Method of pain assessment(Numerical Rating Scale”0-10”) at 1,6,12,24th after the surgery, will be explained to patients. The night before the TAH, cases will be divided into 3 groups;1)Melatonin, 2)Pregabalin, 3)Control group. Anesthetic method will be the same in all 3 groups. Patient monitoring performed with SaO2, ECG, CO2 monitoring and Blood Pressure control. Blood Clot ( 5 cc )will be taken just before and after the operations. Pain intensity should be assessed with NRS scoring(0-10). Post operative pain control will be alleviate with Fentanil(NRS>4). All medical side effects will be assessed. Ondansetron will be prescribed in consider to Nausea.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090816325N3
Registration date: 2015-12-09, 1394/09/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-09, 1394/09/18
Registrant information
Name
Katayoun Haryalchi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
haryalchi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research-Guilan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment on the effect of Melatonin on Pain control after Abdominal Hystrectomy
Public title
Assessment on the effect of Melatonin on Pain control after Abdominal Hystrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:Totalm Abdominal Hystrectomy; Age 35-55; ASA I,II Exclusion criteria: Patients in consider to Cardial; Pulmonary; hepatic; Renal; autoimmune; pscychologic; gastrointestinal diseases; Diabetis; sleep disorders; Epilepsia; Nystagmous; Leukemia; speech and hearing disorders; seasonal and drug allergies; chronic analgesia; hypnotics; pscychotropic; opioid; Beta blockers and MAOI consumption; adverse drug reactions; patients refuse to collaboration.
Age
From 35 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.GUMS.REC.1394.230

Health conditions studied

1

Description of health condition studied
Pain after abdominal hystrectomy
ICD-10 code
N99.9
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified

Primary outcomes

1

Description
Pregabalin(50 mg) with a glass of water
Timepoint
Two hours before the surgery
Method of measurement
mg/kg

2

Description
Melatonin
Timepoint
Two hours before the surgery
Method of measurement
Mg/kg

3

Description
Fentanyl
Timepoint
Hours(1-6-12-24)
Method of measurement
µg/kg

Secondary outcomes

1

Description
Intense of pain
Timepoint
During first hour after the
Method of measurement
surgery

2

Description
Serum Melatonin
Timepoint
During first hour after the surgery
Method of measurement
pg/mL

3

Description
Serum Beta Endorphin
Timepoint
During first hour after the surgery
Method of measurement
ng/L

Intervention groups

1

Description
No prescription 2 hours before the TAH in control group
Category
Treatment - Drugs

2

Description
Melatonin Tablet(5 mg) prescription 2 hours before the TAH in intervention group
Category
Treatment - Drugs

3

Description
Pregabalin Capsule(50 mg) prescription 2 hours before the TAH in intervention group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
KatayounHaryalchi
Street address
Alzahra Hospital- Namjoo Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research-Guilan University of Medical Sciences
Full name of responsible person
Dr. A. Heidarzade
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences Namjoo Street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research-Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Dr.Katayoun Haryalchi
Position
Assistant Professor of Guilan university of Medical Sciences
Other areas of specialty/work
Street address
Rasht, Namjo street, Alzahra hospital, Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 4253 6263
Fax
Email
k_haryalchi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Katayoun Haryalchi
Position
Assistant Professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Centre. Alzahra Hospital. Namjoo Street. Rasht. Guilan. Islamic Republic of Iran
City
Rasht
Postal code
Phone
+98 1301342536263
Fax
Email
k_haryalchi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S.Midwife
Other areas of specialty/work
Street address
Reproductive Health Research Centre. Alzahra Hospital. Namjoo Street. Rasht. Guilan. Islamic Republic of Iran
City
Rasht
Postal code
Phone
00
Fax
Email
k_haryalchi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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