NCT02803788

Brief Summary

  • To study the efficacy and side effects of ondansetron with dexamethasone in patients undergoing standard laparoscopic cholecystectomy (control group).
  • To study the efficacy and side effects of ramosetron in patients undergoing standard laparoscopic cholecystectomy (study group).
  • To compare the efficacy and side effects of ondansetron with dexamethasone and ramosetron in patients undergoing standard laparoscopic cholecystectomy

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

July 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 14, 2016

Last Update Submit

June 14, 2016

Conditions

Postoperative Nausea and Vomiting

Keywords

ramosetron, ondansetron, dexamethasone,

Outcome Measures

Primary Outcomes (1)

  • Comparison of antiemetic effect of Ramosetron with combination of Ondansetron and Dexamethasone in patients undergoing laparoscopic cholecystectomy

    patients will be monitored for vitals, nausea, vomiting, any adverse effect of drug and pain in post-operative period upto 48hrs

    0-48 hrs post-operative period

Study Arms (2)

Group O

ACTIVE COMPARATOR

this group will receive inj. ondansetron 4mg iv stat and inj. dexamethasone 8mg iv stat just before extubation.

Drug: ramosetron, ondansetron, dexamethasone

Group R

EXPERIMENTAL

this group will receive inj. ramosetron 0.3mg iv stat just before extubation.

Drug: ramosetron, ondansetron, dexamethasone

Interventions

ramosetron, ondansetron, dexamethasoneDRUG

prevention of post-operative nausea vomiting

Also known as: anti-emetics
Group OGroup R

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients of age group 20 - 40years undergoing elective laparoscopic cholecystectomy
  • ASA Physical Status- I \& II

You may not qualify if:

  • Negative consent
  • History of motion sickness
  • Pregnancy
  • Menstruating females
  • Antiemetic taken within 24 hours before surgery or any long term medication
  • History of any systemic diseases, cardio- respiratory, hepato-renal, neurological, endocrinal disorders, hematological disorders, drug or alcohol addiction, psychiatric diseases, study drug sensitivity, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GMC Haldwani

Haldwani, Uttarakhand, India, 263139, India

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetronOndansetronDexamethasoneAntiemetics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAutonomic AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesGastrointestinal Agents

Central Study Contacts

C P Bhaisora, MD

CONTACT

05946228393principal.gmchld@rediffmail.com

A K Pandey, MD

CONTACT

05946235444telemedgmchld@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
COMPARATIVE STUDY OF ANTIEMETIC EFFECT OF RAMOSETRON WITH COMBINATION OF ONDANSETRON AND DEXAMETHASONE IN PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)