NCT02726308

Brief Summary

Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy

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 phase_2

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 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
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 29, 2016

Last Update Submit

March 29, 2016

Conditions

Nausea and Vomiting, Postoperative

Keywords

DexamethasoneSuper-hydrationLaparoscopic CholecystectomyNauseaVomitingPostoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative Nausea and Vomiting (PONV)

    A nurse, who was unaware about the groups to which the patient belonged, evaluated patients at 0, 6, and 24 h after surgery for any symptoms of nausea, retching, or vomiting. PONV is classified as early, if occurring up to 6h after surgery, or late, if occurring between 6 h up to 24 postoperatively. A Verbal Descriptive Scale (VDS), was used to assess the severity of PONV: no PONV (grade 0), mild PONV (grade 1), moderate PONV (grade 2) and severe PONV (grade 3)

    Within the first 24 hours postoperatively

Secondary Outcomes (6)

  • Total number of patients who had nausea, vomiting or retching

    Within the first 24 hours postoperatively

  • Antiemetic usage

    Within the first 24 hours postoperatively

  • Pain Score

    Within the first 24 hours postoperatively

  • Total analgesic consumption

    Within the first 24 hours postoperatively

  • Incidence of wound infection

    Within the first week postoperatively

  • +1 more secondary outcomes

Study Arms (2)

Dexamethasone Group

ACTIVE COMPARATOR

I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.

Drug: DexamethasoneDrug: 10 ml/kg Ringer's lactate

Dexamethasone and super-hydration Group

ACTIVE COMPARATOR

I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution

Drug: DexamethasoneDrug: 30 ml/kg Ringer's lactate

Interventions

DexamethasoneDRUG

5 mg I.V. Dexamethasone just before induction

Also known as: Decadron
Dexamethasone GroupDexamethasone and super-hydration Group
10 ml/kg Ringer's lactateDRUG

Intra-operative 10 ml/kg Ringer's lactate solution .

Also known as: Normal hydration
Dexamethasone Group
30 ml/kg Ringer's lactateDRUG

Intra-operative 30 ml/kg Ringer's lactate solution .

Also known as: super-hydration
Dexamethasone and super-hydration Group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy

You may not qualify if:

  • Steroids use within the last 3 days before surgery Antiemetic use within the last 3 days before surgery Opioids use within the last 3 days before surgery. Patients with liver, cardiac or renal diseases Patients with Pregnancy Patients with Bmi ˃ 30kg/m2 Patients with Delayed wound healing Open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Interventions

DexamethasoneCalcium DobesilateRinger's Lactate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • sayed abd elshafy, MD

    associate professor of anesthesia and critical care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

EG(1)