Unique ID issued by UMIN | UMIN000011866 |
---|---|
Receipt number | R000013873 |
Scientific Title | Effects of magnesium sulphate on attenuation of the pain caused by propofol intravenous injection and anesthetic requirements: A Randomized Controlled Trial |
Date of disclosure of the study information | 2013/09/30 |
Last modified on | 2015/09/01 14:12:27 |
Effects of magnesium sulphate on attenuation of the pain caused by propofol intravenous injection and anesthetic requirements: A Randomized Controlled Trial
Multimodal Effects of magnesium for general anesthesia
Effects of magnesium sulphate on attenuation of the pain caused by propofol intravenous injection and anesthetic requirements: A Randomized Controlled Trial
Multimodal Effects of magnesium for general anesthesia
Japan |
Healthy adult patients undergoing elective surgery
Anesthesiology | Adult |
Malignancy
NO
We investigate the effects of magnesium sulfate on attenuation of the pain caused by propofol intravenous injection. Further, stabilization of the concentration of propofol for achieving hypnosis, the effect of promoting the expression of muscle relaxants, suppression of postoperative shivering, the effect of postoperative analgesia, are compared with the saline group.
Safety
Confirmatory
Pragmatic
Phase III
1)vascular pain with propofol
2)vascular pain with magnesium
3)time to asleep onset with propofol 4)concentration of propofol at the time of conscious loss
1)frequency of shivering
2)postoperative pain
3)analgesic requirements
4)muscle relaxant requirement during surgery
5)time to onset of muscle relaxant
6)time to awake from anesthesia
7)hemodynamic changes at the induction of general anesthesia
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
Intravenous administration of magnesium sulfate 5mL(2.5mmol) before propofol
Intravenous administration of saline 5mL before propofol
18 | years-old | <= |
60 | years-old | > |
Male and Female
Patients (American Society of Anesthesiologists physical status I-II) scheduled for elective surgery under general anesthesia without a combination of nerve block.
1)Daily intake Ca blocker
2)Daily intake antipsychotics
3)Having heart, liver or kidney comprication
4)BMI over 35
5)Having arrhythmia, or AV block
6)Preoperative blood magnesium concentration over 2.6mg/dL
7)Not obtained informed consent
50
1st name | |
Middle name | |
Last name | Yukitoshi Niiyama |
Sapporo Medical University, School of Medicine
Department of Anesthesiology
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
011-611-2111(ext.3568)
niiyama@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Nobuyoshi Matsuoka |
Sapporo Medical University, School of Medicine
Department of Anesthesiology
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
011-611-2111(ext.3568)
nobu_xt7@hotmail.com
Sapporo Medical University, School of Medicine
None
Self funding
None
None
None
NO
札幌医科大学付属病院(北海道)
2013 | Year | 09 | Month | 30 | Day |
Unpublished
Terminated
2013 | Year | 09 | Month | 06 | Day |
2013 | Year | 09 | Month | 30 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 25 | Day |
2015 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013873
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |