comparision between Aprepitant and Dexamethasone For Preventing Postoperative Nausea And Vomiting In Breast Cancer Patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/12/005333
• Date of registration: 30-12-2014
• Prospective Registration: Yes
• Primary sponsor: AIIMS
• Public title: comparision between Aprepitant and Dexamethasone For Preventing Postoperative Nausea And Vomiting In Breast Cancer Patients
• Scientific title: Aprepitant Versus Dexamethasone For Preventing Postoperative Nausea And Vomiting In Breast Cancer Patients
• Date of first enrolment: 01-01-2015
• Target sample size: 160
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9192
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Double Blind Double Dummy
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: SACHIDANAND JEE BHARATI
• Affiliation: ALL INDIA INSTITUTE OF MEDICAL SCIENCES

• Name: SACHIDANAND JEE BHARATI
• Affiliation: ALL INDIA INSTITUTE OF MEDICAL SCIENCES

Key inclusion & exclusion criteria

Inclusion criteria: Patients scheduled for elective surgery of age >18yrs with breast cancer, ASA grade 1-3
Exclusion criteria: patients who had a history of drug abuse, hypersensitivity reaction, nausea and received antiemetic before surgery within 24 hours, pregnancy, breastfeeding status

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: null- Patients scheduled for elective surgery of age 18yrs with breast cancer, ASA grade 1-3

Intervention(s)

Intervention1: Aprepitant: Patients in group I will receive 80 mg oral Aprepitant 3 hours before induction of anesthesia
Control Intervention1: Dexamethasone: Patients in group II will receive 8mg dexamethasone intravenously at the time of induction of anesthesia

Primary Outcome(s)

The primary efficacy variable will be episodes of nausea and or vomiting in the early and late postoperative period in first 24 hoursTimepoint: The primary efficacy variable will be episodes of nausea and or vomiting in the early and late postoperative period in first 24 hours

Secondary Outcome(s)

The incidence of any adverse reaction to treatment in the two experimental groups will be recordedTimepoint: till discharge

Secondary ID(s)

NIL

Source(s) of Monetary Support

All India Institute of Medical Sciences

Ethics review

Status: Approved
Approval date: 24/10/2014
Contact:

Institue Ethics Committee,AIIMS

Results

• Date Completed: 31/07/2018