Postoperative Nausea and Vomiting: to Estimate the Incide... | NCT02689128

Studies
Postoperative Nausea and Vomiting: to Estimate the Incidence and Risk Factors in a Tertiary Teaching Hospital

NCT02689128

Sponsor

University of Jordan

Status

Unknown status

Last Update Posted

Feb 23, 2016Estimated

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Postoperative Nausea and Vomiting

Interventions

Not provided

Countries

Jordan

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 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Feb 18, 2016

First Submission Date that Met QC Criteria

Feb 22, 2016

First Posted Date

Feb 23, 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 22, 2016

Last Update Posted Date

Feb 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Subhi M. Alghanem, Professor of Anesthesia and Intensive Care, University of JordanPrincipal Investigator

Lead Sponsor

University of JordanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia.

The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Detailed Description

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia, in the literature it reaches up to 70% of the surgical patients and it occurs after local and general anesthesia with surgery.

Locally in Jordan there was no proper clinical study to estimate PONV among surgical patients, the aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Measure	Description	Time Frame
Postoperative nausea and vomiting		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who undergoes anesthesia and surgery.
Patients who suffer from postoperative nausea and vomiting for 24 hours.

Exclusion Criteria:

Patients who suffer from postoperative nausea and vomiting after 24 hours.
Patients who undergoes Day-case surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who undergoes anesthesia and surgery and suffer from postoperative nausea and vomiting for 24 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Subhi M Alghanem, FFARCS	Contact	00962795640592		alghanem@ju.edu.jo

Overall Officials

Name	Affiliation	Role
Subhi M Alghanem, FFARCS	University of Jordan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Jordan	Recruiting	Amman		11942	Jordan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23431652	Background	Hambridge K. Assessing the risk of post-operative nausea and vomiting. Nurs Stand. 2013 Jan 2-8;27(18):35-43. doi: 10.7748/ns2013.01.27.18.35.c9486.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive

ID	Term
D020250	Postoperative Nausea and Vomiting
D009325	Nausea
D014839	Vomiting