NCT01352130

Brief Summary

Postoperative nausea and vomiting \[PONV\] are common and distressing symptoms after surgery performed under general anaesthesia. 5HT3 antagonists are routinely used for prevention as well as treatment of PONV. After IRB approval we compared the effects of ondansetron and granisetron on the various intervals on ECG in 70 patients undergoing elective surgery for carcinoma breast after written informed consent. The demographic data was collected. The administration of the anaesthetic was left to the discretion of the operating room staff specialist. In the Postoperative Recovery Room patients were randomised to receive 8 mgs of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at 0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse rate, Non-invasive blood pressure and SpO2 were also recorded. T

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

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

March 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

1 month

First QC Date

May 9, 2011

Last Update Submit

May 10, 2011

Conditions

Prolonged QTc Interval

Keywords

Postoperative nausea and vomitingOndansetronGranisetronQTc interval

Outcome Measures

Primary Outcomes (1)

  • Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration

    Both drugs are known to prolong QTc and other ECG intervals

    0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

Patients given Ondansetron

Drug: Ondansetron

Granisetron

ACTIVE COMPARATOR

Patients given Granisetron

Drug: Granisetron

Interventions

OndansetronDRUG

Intravenous Ondansetron 8 mgs

Also known as: 5HT3 antagonists
Ondansetron
GranisetronDRUG

Intravenous Granisetron 1 mgs

Also known as: 5HT3 antagonists
Granisetron

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients undergoing breast surgery for carcinoma breast.
  • Patients between ages 18 to 60 years.
  • ASA I \\ II \\ III
  • Patients weight between 40 and 70 kilograms.

You may not qualify if:

  • Patient refusing consent
  • Prophylactic anti emetic drug administration during intraoperative period
  • Known case of prolonged QTc interval
  • Known case decompensated cardiomyopathy
  • Known case of cardiac arrhythmia or bundle branch block
  • Case of congestive heart failure with left ventricular ejection fraction \<40%
  • Abnormal serum level of potassium, calcium, magnesium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hopsital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (1)

  • Ganjare A, Kulkarni AP. Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial. Indian J Anaesth. 2013 Jan;57(1):41-5. doi: 10.4103/0019-5049.108560.

    PMID: 23716765DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

OndansetronGranisetron

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-RingAzabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Atul P Kulkarni, MD Anaes

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 11, 2011

Study Start

March 1, 2007

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

IN(1)