In this study, which is carried out on 173 patients in Sabzevar Hospital, Propofol and Thiopental are compared to postoperative need for opioid analgesics. Propofol is a substitute for thiopental. Patients were randomly divided into two groups of study (87 patients) and control (86 patients). The study was performed(Patients did not know the type of medicine) in the IV phase of the study. Anesthesia induction was carried out in the study group with propofol 2 mg / kg, and the control group was 5 mg / kg thiopental. In both groups, heart rate was measured and recorded before induction, after the induction, minutes 1, 5, and 10 after the tracheal intubation. In the 1-2-3-4 hours after the operation, the pain intensity is assessed by the visual scale of the pain.
Surgery that lasts more than an hour, and all people with a history of systemic illness and drug addiction are excluded from the study.
General information
Acronym
Patients were randomly divided into two groups (87 patients) and control (86 patients).
IRCT registration information
IRCT registration number:IRCT2017110733202N6
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Atefeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 9180
Email address
a.asadi.mm.1384@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthesia by sodium thiopental with propofol in reducing the need for opiate after tibiofibular fracture surgery
Public title
Comparison of anesthesia by sodium thiopental with propofol in reducing the need for opiate after tibiofibular fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
exclusion criteria: In case of anxiety and lack of response to fentanyl; Surgery longer than 2 hours; All people with a history of systemic disease (cardiovascular, respiratory, hypertension, diabetes, etc.); Patients at risk for nausea and vomiting; Patients with drug addiction or drug addiction.
Inclusion criteria: Have personal consent; Surgery is elective.
Age
From 15 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
173
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
00
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Pardis University
City
Sabzevar
Postal code
Approval date
2017-03-15, 1395/12/25
Ethics committee reference number
ir.medsab.rec.1395.146
Health conditions studied
1
Description of health condition studied
Reducing the need for opiate after tibiofibular fracture surgery
ICD-10 code
m96.6
ICD-10 code description
Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate Excl.: complication of internal orthopaedic devices, implants or grafts (T84.-)
Primary outcomes
1
Description
Pain intensity
Timepoint
1-2-3-4 hours after surgery
Method of measurement
Visual Scale of Pain
2
Description
Heart rate
Timepoint
1-2-3-4 hours after surgery
Method of measurement
Examination
3
Description
Narcotic
Timepoint
1-2-3-4 hours after surgery
Method of measurement
MG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After placement of patients on the bed, the necessary monitoring is performed and all injections of midazolam (0.05 mg / kg) and morphine (0.1 mg / kg) are given as premedication.
5 / 0mg / kg intravenous lidocaine is given 90 seconds prior to intubation. Anesthesia induction is performed in the intervention group with propofol 2 mg / kg. Then, 0.5 kg / kg of atracurium was given to both groups and after an intra-chest tracheal intubation of 3 minutes. In both groups, the blood pressure in the heart was measured and recorded before induction (post-prandial) as the base, after induction, minutes 1, 5, and 10 after intubation.
Category
Treatment - Drugs
2
Description
Control group: After placement of patients on the bed, the necessary monitoring is performed and all injections of midazolam (0.05 mg / kg) and morphine (0.1 mg / kg) are given as premedication.
0.5 mg / kg intravenous lidocaine was given 90 seconds before intubation. Anesthesia was induced in the control group with 5 mg / kg sodium thiopental. Then, 0.5 kg / kg of atracurium was given to both groups and after an intra-chest tracheal intubation of 3 minutes. In both groups, the blood pressure in the heart was measured and recorded before induction (post-prandial) as the base, after induction, minutes 1, 5, and 10 after intubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emdad Hospital - Koshk Street
Full name of responsible person
Adeleh Abdolali zadeh
Street address
Koshk Street
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
fereshteh ghorat
Street address
Pardiss university
City
Sabzevar
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 of Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Asadbadi Street
City
Sabzevar
Postal code
Phone
+98 51 4401 1028
Fax
Email
9151737407mn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical scinse
Full name of responsible person
Mohammad Nematshahi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Asadbadi Street
City
Sabzevar
Postal code
Phone
+98 51 4401 1028
Fax
Email
9151737407mn@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical sciense
Full name of responsible person
Atefeh Asadi
Position
GP
Other areas of specialty/work
Street address
Talghani Street
City
Sabzevar
Postal code
Phone
+98 51 4422 9180
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)