Protocol summary

Summary
The study is a double-blinded, experimental and clinical trial. It will be accomplished after inform consent, on 102 cases, between 35-55 years old. All patients have undergone abdominal hysterectomy under general anesthesia. Sampling will be done from January 2014 to January 2015. Cases with same inclusion criterion, will put in three different groups(1-2-3) with Random-Block method. In this respect, cases will be divided into three groups(1, 2, 3), and a pocket will be allocated to them. Patients will be received one of the pockets by one of the colleagues who do not know about contents. The groups arrang in this manner: 1)Will receive bolus Mg-sulphate(50%)(50mg/kg) during 15 minutes, before the induction. 2)Will receive 50mg/kg ,bolus of Mg-sulphate(during 15 minutes) before the induction and then 15 mg/kg/hr continuously. 3) Will receive just 100 ml of Normal saline. Injections will be performed by colleagues blindly. Monitoring should be performed with ECG, sphygmomanometer, pulse-oxymetery and nerve-stimulator. After 6 hours fasting, induction will be exerted with sodium thiopental, succynil-choline and Fentanyl. Then maintenance should be accomplished with Isoflurane,O2,/N2O, Atracurium and incremental doses of Fentanyl. Patients will be reversed with Neostigmine and Atropine.All cases will be monitored according to PR(pulse rate),BP(blood pressure) throughout 24 hours. Pain score will be recorded with Visual Analogue Scale(VAS), 1-6-18-24 hours after the surgery. With VAS more than 4;Pethidine with dose of 0.5 mg/kg will be recommended. The time interval between the end of surgery and the first dose of Pethidine will be accounted as Analgesic Time.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012316325N1
Registration date: 2014-03-06, 1392/12/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-06, 1392/12/15
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
2014-03-03, 1392/12/12
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An assessment on efficacy of intravenous magnesium sulphate on pain relief after abdominal hystrectomy
Public title
An assessment on intravenous magnesium sulphate on pain relief after abdominal hystrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:Age between 35-55; ASA I,II; No previous abdominal surgeries; systemic major cardiovascular diseases; musculoskeletal disorders; hepatic diseases; Calcium beta-blocker consumption; No previous renal insufficiency; nephropathy; myopathy; No allergy to Mg sulphate or other drugs; No drug abuse Exclusion criteria: Surgeries which will lasted more than 1 hour
Age
From 35 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 102
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 Science
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
5920341308

Health conditions studied

1

Description of health condition studied
Hysterectomy
ICD-10 code
N99.9
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified

Primary outcomes

1

Description
Pain severity
Timepoint
1-6-18-24 hours
Method of measurement
Visual Analog Scale(VAS)

Secondary outcomes

1

Description
Adverse drug reaction
Timepoint
1-6-18-24 hours
Method of measurement
History

2

Description
Pethidine consumption
Timepoint
1-6-18-24 hours
Method of measurement
Whole pethidine dose usage

Intervention groups

1

Description
Administration of bolus Mg-sulphate (50%) (50mg/kg) during 15 minutes, before the induction.
Category
Treatment - Drugs

2

Description
Administration of Mg-sulphate with dose of 50mg/kg (bolus) (during 15 minutes) before the induction and then 15 mg/kg/hr continuously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences-Rasht-Iran
Full name of responsible person
Dr. Abdolrasol Sobhani
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-Rasht-Iran
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 Anesthology of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
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 Anesthology of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Centre, Alzahra Hospital, Namjoo Street
City
Rasht
Postal code
Phone
+98 13 1322 5624
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 Center, Alzahra hospital, Namjoo street
City
Rasht
Postal code
Phone
00
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
Loading...