NCT02947672

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

October 24, 2016

Last Update Submit

February 11, 2018

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea and vomiting (PONV)

    PONV will be measured by using Verbal Descriptive Scale

    24 hours

Secondary Outcomes (1)

  • Pain

    24 hours

Study Arms (2)

Intravenous dexamethasone

ACTIVE COMPARATOR

50 patients will receive intravenous dexamethasone

Drug: Intravenous Dexamethasone

Intra peritoneal dexamethasone

ACTIVE COMPARATOR

50 patients will receive intraperitoneal dexamethasone

Drug: Intraperitoneal Dexamesathone

Interventions

Intravenous DexamethasoneDRUG
Intravenous dexamethasone
Intraperitoneal DexamesathoneDRUG
Intra peritoneal dexamethasone

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult Female patients
  • American society of anesthesiologist class I \& II
  • Undergoing Laparoscopic gynecological surgeries

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 28, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

EG(1)