Determining the effects of low intraocular neostigmine in spinal anesthesia in lower abdominal surgery
Design
In this research, 90 patients who were Candidated for lower abdominal surgery with spinal anesthesia and refered to Emam Reza Hospital were chosen. Then, patients were randomly divided into three groups of control and intervention .
Settings and conduct
This study was performed in Imam Reza Hospital in Mashhad.
The patient and anesthetist nurse were not aware from the type of drug and the groups.
Participants/Inclusion and exclusion criteria
After obtaining the approval of the University Ethics Committee and the satisfaction of patients with ASA I, II, candidates for lower abdominal surgery in the age range of 20-60 years old entered the study.
Intervention groups
Group1: Neostigmine 5 μg (0.1 ml) (chemotherapy drug) with 3 ml of Hyperbaric bupivacaine (15 mg) and 20 μg fentanyl (0.4 ml).
Group2: 3 ml of Hyperbaric bupivacaine in interatcal and 0.5 ml of normal saline
Group3: 3 ml bupivacaine Hyperbaric (15 mg) and 25 μg fentanyl (0.5 ml)
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N6
Registration date:2018-02-07, 1396/11/18
Registration timing:retrospective
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-10-30, 1396/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Low Dose Intrathecal Neostigmine in spinal anesthesia for lower abdominal surgery
Public title
Effects of Low Dose Intrathecal Neostigmine in spinal anesthesia for lower abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20-60 years-old
Candidate for lower abdominal surgery
ASA I,II
90 patients were randomly assigned to random number generator (Wichmann and Hill, 1982, modified by Mcleod, 1985) from the WWW.randomization.com site and evenly divided into three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesiologist nurse and patient are not aware of the groups and type of used drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St., Mashhad Mashhad Khorasan Razavi Iran, 13944-91388
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.MUMS.REC.1394.208
Health conditions studied
1
Description of health condition studied
Abdominal Surgery
ICD-10 code
ICD-10-CM
ICD-10 code description
Lower abdominal pain, unspecified
Primary outcomes
1
Description
PAIN
Timepoint
After operation
Method of measurement
VAS scale
Secondary outcomes
1
Description
heart beat
Timepoint
during operation
Method of measurement
Heart contraction
2
Description
blood pressure
Timepoint
during operation
Method of measurement
device
Intervention groups
1
Description
Intervention group: Neostigmine 5 μg (0.1 ml) (chemotherapy drug) with 3 ml bupivacaine Hyperbaric (15 mg)(Marcaine_, AstraZeneca, Sweden) and 20 μg fentanyl (0.4 ml)) Chemotherapy Company.
Category
Prevention
2
Description
Control group: 3 ml of Hyperbaric bupivacaine in interatcal and 0.5 ml of normal saline
Category
Prevention
3
Description
Control group: 3 ml bupivacaine Hyperbaric (15 mg) and 25 μg fentanyl (0.5 ml)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Morteza Hoseini
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad, Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2712
Email
hoseinimr941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahryar Mirheidari
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St., Mashhad. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3843 3363
Email
ramresearch@mums.ac.ir
Grant name
Vice chancellor for research, Mashhad University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Akipour
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Square Taghi-Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
Alipourm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Square Taghi-Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
Alipourm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Golhasani
Position
Master
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Square of Taghi Abad, Imam Reza Hosital, Anesthesia Research Center. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 802 2711
Email
Golhasanif1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
resulte
When the data will become available and for how long
after publishing
To whom data/document is available
people working in academic institutions or people working
Under which criteria data/document could be used
citation to results
From where data/document is obtainable
sent email to hoseinimr941@mums.ac.ir
What processes are involved for a request to access data/document