This is a randomized double blind clinical trial for assessment the impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy. Inclusion criteria are: women who are 35 till 55years old (with ASA class I&II) without history of susceptible diseases for post-operative nausea and vomiting; not having chronic constipation, IBS and IBD; no history of drug allergies; addiction to opioids; no history of renal, hepatic or respiratory diseases; no history of twice laparatomy or more or organ transplantation. Exclusion criteria are: duration of operation more than two hours; other operation accompany by hysterectomy; incidence of operation’s or anesthesia's side-effects and patients that have hypertension. Sixty six women are randomly assigned into the two groups. Subjects will receive either oral Methylnaltrexone or placebo two hours before operation. All of the study participants will receive general anesthesia with same medications and undergo to the operation by one gynecologist. After operation and stable vital signs, their bowel sounds in 12, 13, 14, … 23,24 hours after operation will be listened every hour for one minute in right lower quadrant of abdomen by one person and other measurements will check one by one.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104121946N8
Registration date:2011-09-13, 1390/06/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-09-13, 1390/06/22
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research-Guilan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy
Public title
An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1) women who were 35-55 years old (with ASA class I&II) .2) without history of susceptible diseases for post-operative nausea and vomiting for example peptic ulcer, gastritis and uses of chemotherapy's drugs. 3) Lack of history about chronic constipation , IBS and IBD. 4) Without history of drug reaction to Naltrexone , another drugs, foods and seasonal allergies or asthma. 5) Lack of kidney's diseases.6) lack of liver's diseases especially hepatitis. 7) lack of addiction to opioids (Tramadol, Morphine, Percocet) and alcohol.8) lack of using psychological drugs/pain reliefer with Codeine or Propoxyphene/ Clonidine/ Disulfiram/ Laxative/ Immunosuppress drugs/ thyroglobulin for diagnose Hashimoto's thyroiditis or hypothyroidism.9) Without history for laparatomy twice or more than. 10) lack of lung's diseases. 11) Without history of organ's transplantation. Exclusion criteria: 1) duration of operation more than two hours.2) existence of another operation accompanied by hysterectomy.3) incidence of oparation's or anesthesia's side-effects.4) hypertension.
Age
From 35 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Vice chancellor for research-Guilan University of Medical Sciences
Street address
Vice chancellor for research-opposite of Azodi Studium-Namjo street
City
Rasht
Postal code
Approval date
2011-05-28, 1390/03/07
Ethics committee reference number
1900136005
Health conditions studied
1
Description of health condition studied
Postprocedural disorders of genitourinary system, not elsewhere classified
ICD-10 code
N99
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified
Primary outcomes
1
Description
An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy
Timepoint
12 hours after operation, every hour
Method of measurement
Patient visits, listening to bowel sounds
Secondary outcomes
1
Description
Assessment of median time of beginning of the bowel sounds
Timepoint
Assessment of median time of beginning of the bowel sounds in first group (patients that received oral Methylnaltrexone)
Method of measurement
Patient visits, listening to bowel sounds
2
Description
Determination of frequency of urinary retention
Timepoint
After fully discharge
Method of measurement
Assessment about patient's ability to urinating
3
Description
Determination of frequency of constipation
Timepoint
after surgery
Method of measurement
Patient visits, question about defecation
4
Description
Determination of frequency of vomiting
Timepoint
after surgery
Method of measurement
Patient visits, question about vomiting
5
Description
Determination of frequency of itching
Timepoint
after surgery
Method of measurement
Patient visits, question on base of itching score
6
Description
Determination of frequency of ileus
Timepoint
12 hours after operation, every hour
Method of measurement
Patient visits, listening to bowel sounds
7
Description
Determination of frequency of side-effects (abdominal pain, bloating ,nausea ,hyperthermia, vertigo ,hypotension)
Timepoint
after surgery
Method of measurement
Patient visit and examine
Intervention groups
1
Description
Intervention group: Oral Methylnaltrexone tablet (25mg); two hours before operation. After operation, bowel sounds in 12,13,….23,24 hours were listened every hour for one minute in right lower quaderant of abdomen and other measurements were checked.
Category
Treatment - Drugs
2
Description
Control group: Placebo oral tablet (25mg); two hours before operation. After operation, bowel sounds in 12,13,….23,24 hours were listened every hour for one minute in right lower quaderant of abdomen and other measurements were checked.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital, Rasht
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research-Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Vice Chancellor for research,Namjoo Ave.
City
Rasht
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-Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mandana Mansur Ghanaie
Position
Associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mandana Mansur Ghanaie
Position
Associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 911 131 3242
Fax
Email
m_m_ghanaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health research center
Full name of responsible person
seyedeh Fatemeh Dalil Heirati
Position
B.S
Other areas of specialty/work
Street address
Reproductive Health research center-Alzahra hospital-Namjo street
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)