Intravenous Versus Intra-peritoneal Dexamethasone on the... | NCT02947672

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

NCT02947672

Sponsor

Assiut University

Status

Completed

Last Update Posted

Feb 13, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Postoperative Nausea and Vomiting

Interventions

Intravenous Dexamethasone
Intraperitoneal Dexamesathone

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Oct 24, 2016

First Submission Date that Met QC Criteria

Oct 26, 2016

First Posted Date

Oct 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2018

Last Update Posted Date

Feb 13, 2018Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intravenous Dexamethasone	Drug		Intravenous dexamethasone
Intraperitoneal Dexamesathone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital		Asyut		71515	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided