Effect of a single dose of Pregabalin on intraoperative hemodynamic changes and duration of analgesia in spinal anesthesia for tibial bone fracture orthopedic surgery
Effect of a single dose of Pregabalin on intraoperative hemodynamic changes and duration of analgesia in spinal anesthesia for tibial bone fracture orthopedic surgery. This study was a randomized clinical trial with two groups Pregabalin (capsules 150 mg) and placebo (drug capsules in appearance, but no active ingredient) to control the dependent variable is the before and after of the intervention. Non-emergency patients in ASA class 1, age 20 to 70 years with tibia fractures in the study of patients with diseases or conditions affecting the hemodynamic status and pain leaving
120 eligible patients hospitalized part Orthopaedic Hospital Khatma Lanbya, in 1393 who is scheduled to undergo surgery Orthopaedic Fracture Tibia spinal anesthesia is reflected by the sampling block with random allocation of both the experimental group and the placebo group with written informed consent to enter the study were check favors, hour before spinal anesthesia, two capsules 75 mg Pregabalin ّFizer manufacturing plant in America or two placebo group consumed that her presence helped the researcher. The mean arterial pressure, pulse, length and number of analgesia after spinal anesthesia is checked. It is assumed that this drug causes hemodynamic stability during long will the pain of spinal anesthesia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121020272N1
Registration date:2015-08-24, 1394/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-24, 1394/06/02
Registrant information
Name
Amir Moosavi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5717
Email address
amir.moosavi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a single dose of Pregabalin on intraoperative hemodynamic changes and duration of analgesia in spinal anesthesia for tibial bone fracture orthopedic surgery
Public title
Effect of pregabalin on hemodynamic on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The non-emergency patients ASA class 1; Age 20 to 70 years; candidates for orthopedic surgery tibia fracture; the prior written consent from patient; social class and level of consciousness that patient is able to cooperate ;
Exclusion criteria were the beginning of the study:
hemodynamic status is affected with diseases or conditions such as heart disease, diabetes, renal ;The history of allergy to gabapentin or Pregabalin, drug use, regular use of alcohol or smoking more than 5 years, the diseases of the brain and nerves ; spinal anesthesia during surgery after more than ninety minutes ; patients who require drugs that affect hemodynamic ; pregnancy ; refusal of doing research and refusal of spinal anesthesia patients ; patients with coagulopathy ; infection in site of the spinal anesthesia ; any interference with the absorption of oral drugs that can cause digestive disorders ; The disease affects the feeling of pain, such as diabetes, drug addiction ; Monitor the patient is indicative of Abnormal pulse , mean arteria presure ; The need for analgesics for pain relief
Exclusion criteria during the study:
Abnormal bleeding during surgery ; Intraoperative cardiovascular and brain complications ; Monitor the patient is indicative of abnormal pulse, mean arterial pressure.
Age
From 20 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Zahedan University of Medical Sciences
Street address
Doctor Hesab square
City
Zahedan
Postal code
9816743463
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
6907
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament
Primary outcomes
1
Description
mean arterial pressure؛ pulse
Timepoint
Thirty minutes before feeding capsules every ten minutes. Every ten minutes after spinal anesthesia to complete the surgery
Method of measurement
Monitoring of vital signs
2
Description
duration of analgesia in spinal anesthesia
Timepoint
After the onset of anelgesia by spinal anesthesia Until the onset of pain
Method of measurement
Timer(minute)
Secondary outcomes
1
Description
No exist
Timepoint
No exist
Method of measurement
No exist
Intervention groups
1
Description
pregabalin group (150 mg capsule): because of 150 mg capsules it's not available on the market of Iran that is given two 75 mg capsules instead. A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect by comparison with the placebo group on the dependent variables arterial medium voltage, pulse duration of analgesia after spinal anesthesia are considered.
Category
Other
2
Description
placebo group (Appearance, but no active ingredient drug capsules ). A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect by comparison with the placebo group on the dependent variables arterial medium voltage, pulse duration of analgesia after spinal anesthesia are considered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Orthopedic Section Hospital
Full name of responsible person
Doctor Alireza Rahat Dahmardeh
Street address
Khatam Hospital, Jame Jam Boulevard
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for research Zahedan University of Medical Sciences
Full name of responsible person
DR Hooshang Rafigh Doost
Street address
Doctor Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for research Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Amir Moosavi
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Khatam Hospital, Jame Jam Boulevard
City
Zahedan
Postal code
9815733169
Phone
+98 54 3322 0501
Fax
+98 54 3322 0504
Email
amir.moosavi@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan Medical Science Univesity
Full name of responsible person
Alireza Rahat Dahmardeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Khatam Hospital, Jame Jam Boulevard
City
Zahedan
Postal code
9815733169
Phone
+98 915 542 0911
Fax
+98 543322504
Email
Dr.dahmardeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Amir Moosavi
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Khatam Hospital, Jame Jam Boulevard
City
Zahedan
Postal code
009815733169
Phone
+98 543220501
Fax
+98 543220504
Email
amir.moosavi@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)