Comparing the effect of acupuncture and traditional pharmacologic therapy on Delayed Gastric Emptying on traumatic patient in ICU of BESAT Hospital, Hamadan
Objective: Comparing the effect of acupuncture and traditional pharmacologic therapy on Delayed Gastric Emptying on traumatic patient in ICU.
Design: Double blind clinical trial.
Population: 60 people from traumatic patients (multiple trauma and head trauma) who are admitted in ICU .
Inclusion criteria: All trauma patients ranges from 18 to 75 years of age who are admitted in ICU and their conditions suitable for Enteral feeding and have Tube feeding intolerance.
Exclusion criteria : Not Satisfied to perform acupuncture, Patients who have contraindications to enteral feeding, age younger than 18 years or older than 75 years, Patients are prohibitive for NG Tube insertion recent major abdominal surgery, , suspected bowel obstruction or perforation, pancreatitis.
In the group receiving the drug: Erythromycin 200mg every 6 hours (syrup) will be used as standard drug. If appropriate response is not seen in patients Metoclopramide as supplemental drug dose 10-20 mg every 8 hours will be used. Acupuncture patient groups: stimulation at frequencies between 7 to 13 MA current 7HZ (depending on the patient's wrist width) is performed. The two stimulation for 20 min and at intervals of every 12 hours (twice a day) for 6 days at the P6 acupuncture point and at a depth of 0.5 cm from the skin surface is performed. Improved as the volume of gastric residual volume less than 200 cc in 24 hours - which is obtained through NGTube - is determined in two consecutive days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112014578N4
Registration date:2012-02-27, 1390/12/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences-vice chancellor for research
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupuncture and traditional pharmacologic therapy on Delayed Gastric Emptying on traumatic patient in ICU of BESAT Hospital, Hamadan
Public title
The effect of acupuncture and traditional pharmacologic therapy on Delayed Gastric Emptying
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All trauma patients ranges from 18 to 75 years of age who are admitted in ICU and his conditions suitable for Enteral feeding and has Tube feeding intolerance.
postoperative days.
Exclusion criteria :
Not Satisfied to perform acupuncture
Patients who have contraindications to enteral feeding
age younger than 18 years or older than 75 years,
Patients are prohibitive for NG Tube insertion
recent major abdominal surgery,
history of partial or total gastrectomy,
suspected bowel obstruction or perforation, pancreatitis, administration
of prokinetic drugs Metoclopramide, cisapride, or
erythromycin) within the previous 24 hours.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University Of Medical Sciences
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
16/35/9/3244/پ/د
Health conditions studied
1
Description of health condition studied
gastroparesis
ICD-10 code
K31
ICD-10 code description
Other diseases of stomach and duodenum
Primary outcomes
1
Description
Volume remaining in the stomach.
Timepoint
Total volume remaining in the stomach during a day
Method of measurement
Through the NG tube attached to the patient
Secondary outcomes
empty
Intervention groups
1
Description
Acupuncture patient groups: stimulation at frequencies between 7 to 13 mA current 7HZ (depending on the patient's wrist width) is performed. The two stimulation for 20 min and at intervals of every 12 hours (twice a day) for 6 days at the P6 acupuncture point and at a depth of 0.5 cm from the skin surface is performed.
Category
Treatment - Devices
2
Description
In the group receiving the drug: Erythromycine 200mg every 6 hours (syrup) will be used as standard drug. If appropriate response is not seen in patients Metoclopramide as supplemental drug dose 10-20 mg every 8 hours will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Farshid Rahimi Bashar
Street address
BESAT Hospital, General ICU, Motahhari Avenue_Resalat square
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences-vice chancellor for research
Full name of responsible person
Dr.Heidar Tavilani
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences-vice chancellor for research
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor/Intensive care fellowship
Other areas of specialty/work
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1821 4230
Fax
Email
fr_rahimibashar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor/Intensive care fellowship
Other areas of specialty/work
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1821 4230
Fax
Email
fr_rahimibashar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)