NCT02525848

Brief Summary

To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

August 14, 2015

Last Update Submit

March 22, 2016

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • incidence (%) of postoperative nausea and vomiting

    The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.

    24 hours postoperative

Secondary Outcomes (3)

  • non invasive blood pressure

    intra-operative from induction of general anesthesia till end of surgery.

  • heart rate

    Intra-operative from induction of anesthesia till end of surgery.

  • side effects

    24 h postoperative.

Study Arms (3)

dexamethasone

ACTIVE COMPARATOR

intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;

Drug: dexamethasone

gapabentin

ACTIVE COMPARATOR

oral gabapentin 600 mg 1 hour before induction of anesthesia

Drug: dexamethasoneDrug: Gabapentin

Aprepitant

ACTIVE COMPARATOR

aprepitan 80mg 1 hour before induction of anesthesia.

Drug: dexamethasoneDrug: Aprepitant

Interventions

dexamethasoneDRUG

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Also known as: Decadron
Aprepitantdexamethasonegapabentin
GabapentinDRUG

oral gabapentin 600 mg 1 hour before induction of anesthesia

Also known as: Neurontin
gapabentin
AprepitantDRUG

oral aprepitan 80mg 1 hour before induction of anesthesia.

Also known as: Emend
Aprepitant

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.

You may not qualify if:

  • Central or peripheral neurological pathologies.
  • History of drug abuse, chronic pain, or psychiatric disorders.
  • Pregnant women
  • Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hala saad Abdel-Ghaffar

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

DexamethasoneCalcium DobesilateGabapentinAprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsAminesgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicAmino AcidsAmino Acids, Peptides, and ProteinsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hala S Abdel-Ghaffar, MD

    Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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
MD

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

EG(1)