Protocol summary

Summary
In this study, the efficacy of melatonin and gabapentin in evaluating the anxiety and postoperative pain in lumbar spine surgery in patients referred to Golestan Hospital General Operative Room. A total of 90 patients were selected randomly in 3 groups of melatonin, gabapentin and placebo. 120 min before induction, melatononin, gabapentine and palacebo groups received 60 mg melatonin, 600 mg gabapentine and 5 ml distilled water, respectively. After transferring patients to surgical room, all will be taken care of under standard monitoring including electrocardiogram, pulse oximetry, non-aggressive blood pressure and heart rate. Meanwhile anxiety level in patients before surgery would be measured with a VAS. After prescription of 10 ml/kg isotonic liquids and preoxygenation for 3 min, all patients with a same procedure, 3 mg/kg midazolam, 2 mg/kg phentanyl, 4 mg/kg STP and 5 mg/kg atracurarium will be anesthesized. After intubation and fixation of tube, the vital symptoms including BP, HR and SpO2 will be measured. Anesthesizing process with 75% oxygen and isoflurane 8%is managed. At the end of the surgery and extubing the patient, the following parameters will be studied. -Need for remedy 1, 2, 6, 12 and 24 h after surgery -Pain intensity using VAS 1, 2, 6, 12 and 24 h after surgery -Satisfaction level of patients of analgesia with a quality score (perfect, good, average and poor) 1, 2, 6, 12 and 24 h after surgery All data will be recorded by a non-informed third person of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100436566N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Iren Amirpour
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 1362
Email address
amirpour.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapor University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effects of melatonin and gabapentin on pain and anxiety following lumbar spine surgery
Public title
Comparison of Effects of melatonin and gabapentin on pain and anxiety following lumbar spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion area: Aged 18 and under 60 years old; ASA class Ὶ and ῚῚ; Spine surgery; Written permission of study entrance Exclusion area: Emergency surgery; tumor surgery; melatonin or gabapentin allergy; BMI higher than 35; pregnancy or breastfeeding; opioid abuse
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Khuzestan, Ahvaz
City
Ahvaz
Postal code
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.AJUMS.REC.1396.86

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified

2

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Pain
Timepoint
2 h before until 24 h after opetration
Method of measurement
Visual Analogue Scale, questionnaire

2

Description
Anxiety
Timepoint
2 h before until 24 h after opetration
Method of measurement
Visual Analogue Scale, questionnaire

Secondary outcomes

1

Description
blood pressure
Timepoint
2 h before until 24 h after operation
Method of measurement
sphygmomanometer

2

Description
heart rate
Timepoint
2 h before until 24 h after operation
Method of measurement
Stetoscope

Intervention groups

1

Description
Oral gabapentin is given at a dose of 600 mg two hours before surgery
Category
Prevention

2

Description
Oral melatonin is given at 6 mg 2 hours before surgery
Category
Prevention

3

Description
Distilled water is used at a rate of 5 ml 2 hours before surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestasn Hospital
Full name of responsible person
Iren Amirpour
Street address
City
Ahvasz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Street address
Faculty of Medicine, Jundishapour University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapor 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
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoshzadeh
Position
Cardiac Anesthesia Fellowship
Other areas of specialty/work
Street address
Farvardin street, Golestan, Golestan Hospital
City
Ahvaz
Postal code
Phone
+98 916 111 4831
Fax
Email
F_javaherforoosh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoshzadeh
Position
Cardiac Anesthesia Fellowship
Other areas of specialty/work
Street address
Farvardin street, Golestan, Golestan hospital
City
Ahvaz
Postal code
Phone
+98 916 111 4831
Fax
Email
F_javaherforoosh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Iren Amirpour
Position
Resident of Aneshtesiology
Other areas of specialty/work
Street address
Golestan, Farvardin street, Golestan hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 1362
Fax
Email
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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