Objective:
The effect of Intrathecal Atropine to prevent Nausea & Vomiting after surgeries due to use Intrathecal Morphine in lower limb surgeries
Design:
Randomized; Double blind; Placebo; Single center
Participants including major eligibility criteria:
The patients aged from 40-70 years
Participants excluding major eligibility criteria:
Patients with history Neurologic disease and Neuromuscular; Diabetes Mellitus; Patients with Neuropathy Peripheral; Infection in site of injection; Sensitivity to Local Anesthesia; Patients with Vomiting and Nausea before surgery or receiving 48 hours before surgery Anti Vomiting and Nausea; Women in period of mense
120 patients
Intervention:
Intrathecal Atropine
Setting and conduct:
Patients divided into 2 groups by random allocation, A and B; Spinal Anesthesia performed for each group with 2.5cc Hyperbaric Bupivacaine 0.5% and 0.2mg (1cc) Intrathecal Morphine. Patients received 0.1mg (1cc) Intrathecal Atropine in group A and 1cc Normal-Saline 0.9%. Then on the basis of provided check-list, The Nausea & Vomiting checked during 24 hours after surgery (every 1 hour for 6 hours after surgery, Then during 6 hours and 12 hours after surgery). The Heart Rate and Blood Pressure changes checked at 3, 5, 10 and 15 minutes after performing Intrathecal Atropine. In this study, The Rate of Analgesia surveyed for 12 hours every 2 hours.
Variables of main outcome:Incidence of Vomiting and Nausea for each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012012204N1
Registration date:2013-12-09, 1392/09/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-09, 1392/09/18
Registrant information
Name
Fatemeh Shima Hadipourzadeh
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 5054
Email address
fhadipourzade@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Intrathecal Atropine to prevent Nausea & Vomiting after surgeries due to use Intrathecal Morphine in lower limb surgeries
Public title
The effect of Intrathecal Atropine to prevent Nausea & Vomiting after surgeries due to use Intrathecal Morphine in lower limb surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Participants including major eligibility criteria:
The patients aged from 40-70 years
Participants excluding major eligibility criteria:
Patients with history Neurologic disease and Neuromuscular; Diabetes Mellitus; Patients with Neuropathy Peripheral; Infection in site of injection; Sensitivity to Local Anesthesia; Patients with Vomiting and Nausea before surgery or receiving 48 hours before surgery Anti Vomiting and Nausea; Women in period of mense
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
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
Ethics Comitia Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Navab Street, Qazvin
City
Qazvin
Postal code
Approval date
2013-02-27, 1391/12/09
Ethics committee reference number
28/20/7034
Health conditions studied
1
Description of health condition studied
Spinal Anesthesia
ICD-10 code
T41.3
ICD-10 code description
local anaesthetics
Primary outcomes
1
Description
Incidence of Vomiting and Nausea
Timepoint
Incidence of Nausea and Vomiting were studied in patients within 24 hours after injection of Atropine: Hourly up to 6 hours, Then 6 hours later and Finally 12 hours later.
Method of measurement
With checklist: Mild; Moderate; Severe
Secondary outcomes
1
Description
Heart Rate
Timepoint
3,5,10,15 Minutes after Spinal Anesthesia with receiving Atropin Interathecal
Method of measurement
Heart Rate per minute
2
Description
Blood Pressure
Timepoint
3,5,10,15 Minutes after Spinal Anesthesia with receiving Atropin Intrathecal
Method of measurement
Blood volume pump by heart
3
Description
With out pain period
Timepoint
Intrathecal Morphine-Induced Analgesia was studied in 2 hours intervals for 12 hours after injection.
Method of measurement
With checklist
Intervention groups
1
Description
GroupB Spinal Anesthesia was induced using 2.5 cc of 0.5 % Hyperbaric Bupivacaine and 0.2 mg (1cc) of Intrathecal Morphine. In addition patients in group B received 1cc of saline 0.9%.
Category
Placebo
2
Description
Group A Spinal Anesthesia was induced using 2.5 cc of 0.5 % Hyperbaric Bupivacaine and 0.2 mg (1cc) of Intrathecal Morphine. In addition patients in groupA received 0.1 mg (1cc) Intrathecal Atropine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Fatemeh Shima Hadipourzadeh
Street address
Shahid Rajaee Hospital, Padegan Street, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Mahnaz Abaci
Street address
Qazvin University of Medical Sciences, Navab Street, Qazvin
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Shima Hadipourzadeh
Position
Resident Anesthesia
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Navab Street
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
fhadipourzade@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Shima Hadipourzadeh
Position
Resident Anesthesia
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Navab Street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
fhadipourzade@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Shima Hadipourzadeh
Position
Resident Anesthesia
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Navab Street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
fhadipourzade@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)