Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting

February 11, 2018 updated by: Eman A. Ismail, Assiut University

Effect of Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting Following Laparoscopic Gynecological Surgeries

Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Adult Female patients
  2. American society of anesthesiologist class I & II
  3. Undergoing Laparoscopic gynecological surgeries

Exclusion Criteria:

  1. Patient refusal to participate in the study
  2. Patients with coagulopathy or under anticoagulation therapy.
  3. Infection near the site of needle insertion.
  4. Body mass index > 40kg/m2
  5. Patients with any neurological or neuromuscular disorder or history of seizures.
  6. Known allergy to any drug used in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous dexamethasone
50 patients will receive intravenous dexamethasone
Drug: Intravenous Dexamethasone
Active Comparator: Intra peritoneal dexamethasone
50 patients will receive intraperitoneal dexamethasone
Drug: Intraperitoneal Dexamesathone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting (PONV)
Time Frame: 24 hours
PONV will be measured by using Verbal Descriptive Scale
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 24 hours
Pain will be assessed by using visual analogue scale
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01003060377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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