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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intravenous Dexamethasone
Intraperitoneal Dexamesathone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravenous dexamethasone

Intra peritoneal dexamethasone

Arm Description

50 patients will receive intravenous dexamethasone

50 patients will receive intraperitoneal dexamethasone

Outcomes

Primary Outcome Measures

Postoperative nausea and vomiting (PONV)
PONV will be measured by using Verbal Descriptive Scale

Secondary Outcome Measures

Pain
Pain will be assessed by using visual analogue scale

Full Information

First Posted
October 24, 2016
Last Updated
February 11, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02947672
Brief Title
Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting
Official Title
Effect of Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting Following Laparoscopic Gynecological Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous dexamethasone
Arm Type
Active Comparator
Arm Description
50 patients will receive intravenous dexamethasone
Arm Title
Intra peritoneal dexamethasone
Arm Type
Active Comparator
Arm Description
50 patients will receive intraperitoneal dexamethasone
Intervention Type
Drug
Intervention Name(s)
Intravenous Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Intraperitoneal Dexamesathone
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting (PONV)
Description
PONV will be measured by using Verbal Descriptive Scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain
Description
Pain will be assessed by using visual analogue scale
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult Female patients American society of anesthesiologist class I & II Undergoing Laparoscopic gynecological surgeries Exclusion Criteria: Patient refusal to participate in the study Patients with coagulopathy or under anticoagulation therapy. Infection near the site of needle insertion. Body mass index > 40kg/m2 Patients with any neurological or neuromuscular disorder or history of seizures. Known allergy to any drug used in the study.
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

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

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