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An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy

An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201104121946N8
Enrollment
66
Registered
2011-09-13
Start date
2011-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprocedural disorders of genitourinary system, not elsewhere classified. Postprocedural disorder of genitourinary system, unspecified

Interventions

Intervention 1: 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. Inter
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.
Treatment - Drugs
Intervention group: Oral Methylnaltrexone tablet (25mg)
Control group: Placebo oral tablet (25mg)

Sponsors

Vice Chancellor for research-Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 55 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.;Determination of frequency of urinary retention. Timepoint: After fully discharge. Method of measurement: Assessment about patient's ability to urinating.;Determination of frequency of constipation. Timepoint: after surgery. Method of measurement: Patient visits, question about defecation.;Determination of frequency of vomiting. Timepoint: after surgery. Method of measurement: Patient visits, question about vomiting.;Determination of frequency of itching. Timepoint: after surgery. Method of measurement: Patient visits, question on base of itching score.;Determination of frequency of ileus. Timepoint: 12 hours after operation, every hour. Method of measurement: Patient visits, listening to bowel sounds.;Determination of frequency of side-effects (abdominal pain, bloating ,nausea ,hyperthermia, vertigo ,hypotension). Timepoint: after surgery. Method of measurement: Patient visit and examine.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mandana Mansur Ghanaie

Guilan University of Medical Sciences

m_m_ghanaie@yahoo.com+98 13 1322 5624

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026