NCT03313479

Brief Summary

Postoperative nausea and vomiting (PONV) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances Incidence of PONV after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

October 7, 2017

Last Update Submit

October 13, 2017

Conditions

Keywords

Nausea, vomiting

Outcome Measures

Primary Outcomes (1)

  • PONV

    incidence of post operative nausea and vomiting

    8 hours post operative

Study Arms (3)

Group 1

GA and Dexmedetomidine

Drug: Dexmedetomidine

group 2

GA and peribulbar

group3

GA and xylocaine gel

Interventions

Dexmedetomidine will be given with GS

Also known as: Dexmedetomidine with scleral buckling
Group 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergo repair of retinal detachment with scleral buckling

You may qualify if:

  • males or females
  • aged between 18-80 years
  • ASA physical status Ι\&II -indicated for repair of retinal detachment with scleral buckling. -

You may not qualify if:

  • Patients with cardiac, liver and/or kidney diseases
  • coagulation defects or receiving anticoagulants
  • hypersensitivity to the used drugs
  • history of motion sickness or PONV
  • diabetes mellitus
  • gastrointestinal disease
  • smokers
  • menstruating ladies
  • ASA status more than II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

Location

MeSH Terms

Conditions

VomitingNausea

Interventions

DexmedetomidineScleral Buckling

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Hassan Ali, lecturer

CONTACT

Ahmed Badwy, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

October 7, 2017

First Posted

October 18, 2017

Study Start

October 30, 2017

Primary Completion

November 30, 2017

Study Completion

January 1, 2018

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations