The aim of this study is evaluation the effect of intraoperative magnesium and ketamine combination on postoperative pain after abdominal hysterectomy. In this randomized double-blind clinical trial, 66 patients, ASA class I and II undergoing abdominal hysterectomy are studied. The study group ( n=33) receive bolus dose of magnesium sulfate (50% Magnesium Sulfate 0.5 gm/ml; Pasteur Institute of Iran)1g into 100ml normal saline over 15 min and bolus ketamine (Ketamine HCL 50 mg/ml; TRITTAU; Germany) 15 mg over 2-3 min prior to induction of anesthesia. Then magnesium sulfate 1g with ketamine 30 mg into 300ml normal saline is infused during surgery until the end of operation. In the placebo group same volume of normal saline (NaCl 500 ml; ُShahid Ghazi Pharmacuetical; Tabriz; IRAN) is infused at the similar times. Intensity of postoperative pain according to VAS in PACU and at 1,3,6,12 and 24 h after surgery, time of first request to analgesic, overall dose of analgesics, time of ambulation and hospitalization, side effects and magnesium values (before and 24h after surgery) are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608157013N12
Registration date:2016-09-04, 1395/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intra-operative magnesium and ketamine combination on pain control after abdominal hysterectomy
Public title
Effect of intraoperative magnesium and ketamine combination on postoperative pain after abdominal hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Scheduled for elective abdominal hysterectomy; ASA class I, II. Exclusion criteria: Emergence hysterectomy; history of systemic diseases (renal, cardiovascular; respiratory, hepatic, neuromuscular and ...); history of psychopathy; BMI>35; calcium Chanel inhibitor consumption; recent magnesium therapy; history of chronic pain syndrome; pregnancy; history of alcohol and opioid consumption
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients were randomly assigned to study group (n = 33), and placebo group (n = 33) using a computer-generated randomization list.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ettics Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.TBZMED.REC.1395.222
Health conditions studied
1
Description of health condition studied
Acute postoperative pain
ICD-10 code
R50-R69
ICD-10 code description
R52.0 Acute Pain
Primary outcomes
1
Description
pain
Timepoint
PACU and at 1, 3, 6, 12 and 24h after surgery
Method of measurement
visual analogue scale(VAS) (0= non to 10= severe pain) cm)
Secondary outcomes
1
Description
Overall dose of postoperative analgesic
Timepoint
PACU and during 24h postoperatively
Method of measurement
number and amount of medication by mg
Intervention groups
1
Description
The study group ( n=33) receive bolus dose of magnesium sulfate 1g into 100ml normal saline over 15 min and bolus ketamine 15 mg over 2-3 min prior to induction of anesthesia. Then magnesium sulfate 1g with ketamine 30 mg into 300ml normal saline is infused during surgery until the end of operation.
Category
Prevention
2
Description
In the placebo group: normal saline 100ml during 15 min before the surgery and 300 ml during surgery are infused.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical education Center
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al-Zahra Hospital, Sought Artesh Street,Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reaserch, Tabriz University of Medical Scienses
Full name of responsible person
Dr. Rashidi
Street address
Vice Chancellor for Research, Building No. 2 Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reaserch, Tabriz University of Medical Scienses
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
Vice chancellor for research, Tabriz University of Medicalُ Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+355 39161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice Chancellor for Research,Tabriz university of Medical sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+355 39161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vice Chancellor for Research,Tabriz university of Medical sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, Sought Artesh Street
City
Tabriz
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)