Postoperative ileus in bowel due to loss of coordinated motility non-mechanical factors caused by their inability to pass gas and stool and food intolerance show. The patient usually nausea, vomiting, severe constipation and abdominal discomfort and pain is publish. This study is a randomized triple-blind clinical trial.The target population included all patients undergoing spinal anesthesia for cesarean section in a hospital in the exercise of Imam Khomeini (RA) is Sari in 1393-1394. Before the start of the list of subjects for the second study group, 60 patients were randomized using a computer to be determined. Sitting patients are Drpvzyshn and space L2-L3 and L3-L4 spinal puncture spinal Basvzn be done. Patients were randomly divided into two groups A and B. Group A) intervention (combination of morphine and naloxone pump PCA contains 30 mg dose of 0.25μg / kg / hr manufacturing pharmaceutical company producing the drug and the rest of the volume of 100 cc (total volume pump PCA) has become saline. group) B (control: internal composition contains 30 mg of morphine PCA pump and the rest of the volume of 100 cc (total volume pump PCA) has become saline. profile settings PCA pump would then be: the 5/0 cc bolus with Lockout 15 minutes and background infusion 2cc / h.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022426357N2
Registration date:2016-08-24, 1395/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
seyed mohamad mehdi daneshpoor
Name of organization / entity
mazandaran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 3371 7189
Email address
mdaneshpour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Science
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ultra low dose naloxone on post-operative ileus after caesarean section by spinal anesthesia
Public title
Effect of naloxone on ileus after caesarean section by spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria (inclusion criteria): The willingness of patients to participate in the study and informed consent; first elective cesarean section under spinal anesthesia; Age> 18 years; ASA Class Ị Exclusion criteria (exclusion criteria): Any contraindication to spinal anesthesia; Taking prokinatic; Irritable Bowel Syndrome; drug addiction;
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
mazandaran university of medical science
Street address
Sari-blvd daneshgah
City
sari
Postal code
Iran
Approval date
2015-02-27, 1393/12/08
Ethics committee reference number
IR.Mazums.rec.94
Health conditions studied
1
Description of health condition studied
ileus
ICD-10 code
K56.7
ICD-10 code description
Ileus, unspecified
Primary outcomes
1
Description
ileus
Timepoint
as soo
Method of measurement
Upon arrival to the recovery room, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 6, 12 and 24 hours after operation
Secondary outcomes
1
Description
pain
Timepoint
Upon arrival to the recovery room, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 6, 12 and 24 hours.
Method of measurement
VAS
2
Description
VOMITING
Timepoint
Upon arrival to the recovery room, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 6, 12 and 24 hours.
Method of measurement
VAS
3
Description
NAUSEA
Timepoint
Upon arrival to the recovery room, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 6, 12 and 24 hours.
Method of measurement
VAS
4
Description
Itching
Timepoint
Upon arrival to the recovery room, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 6, 12 and 24 hours after surgery
Method of measurement
VAS
Intervention groups
1
Description
Group A) intervention (combination of morphine and naloxone pump PCA contains 30 mg dose of 0.25μg / kg / hr manufacturing pharmaceutical company producing the drug and the rest of the volume of 100 cc (total volume pump PCA) has become saline.
Category
Treatment - Drugs
2
Description
group) B (control: internal composition contains 30 mg of morphine PCA pump and the rest of the volume of 100 cc (total volume pump PCA) has become saline. profile settings PCA pump would then be: the 5/0 cc bolus with Lockout 15 minute infusion 2cc / h
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
imam khomeini hospital
Full name of responsible person
atefeh hadian
Street address
amir mazandarani avenue
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
atefeh hadian
Street address
Imam Khomeini
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Science
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
Mazandaran University of Medical Science
Full name of responsible person
Atefeh Hadian
Position
Ansthesiology Resident
Other areas of specialty/work
Street address
Sari Amirmazandarani
City
Sari
Postal code
Phone
+98 11 3226 1700
Fax
Email
md.hadian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Aefeh Hadian
Position
Ansthesiology Resident
Other areas of specialty/work
Street address
Amirmazandarani Blvd
City
Sari
Postal code
Phone
+98 11 3226 1700
Fax
Email
md.hadian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Atefeh Hadian
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 11 3226 1700
Fax
Email
md.hadian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)