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

Completed

• Conditions: Malignant neoplasm of breast of unspecified site, Patients scheduled for elective surgery of age 18yrs with breast cancer, ASA grade 1-3,

• Registration Number: CTRI/2014/12/005333
• Lead Sponsor: AIIMS

Brief Summary

Postoperative nausea and vomiting (PONV) is a major cause of morbidity in surgical patients. Several factors including age, gender, type of surgery and anesthetic agents, intraoperative opioid use, and duration of anesthesia, have been implicated as the causes of PONV. Variety of new drugs and anesthetic techniques has been introduced in the recent past to reduce PONV; however, the incidence still remains significantly high, ranging between 25% and 30% even after multimodal antiemetic regimens.

Breast surgery is associated with high incidence of PONV, ranging between 15% and 84%. Oncologic breast surgical procedures have been reported to have increased incidence of PONV. Patients with no known risk factors carries 10% risk of PONV and it increases exponentially to 61% and 79%, respectively, when 3 or 4 risk factors exist (female gender, nonsmoker, history of motion sickness, postoperative opioid use and a history of PONV).

In the recent times, studies have demonstrated the relationship between substance P, the CNS and emesis center. A new class of non-peptide neurokinin1 receptor antagonists (NK1RAs), demonstrated to have activity against both peripheral and central emetic stimuli. Human trials have examined NK-1 antagonists in the prevention of PONV, showing a decreased incidence. Aprepitant may have antiemetic effects beyond 48 h after surgery with special impact on post-discharge nausea and vomiting. Aprepitant, a highly selective, brain-penetrant NK-1 RA with a long half-life and preclinical efficacy against opioid-induced emesis, has demonstrated efficacy against chemotherapy-induced nausea and vomiting when combined with other antiemetic, and is the first in its class to be approved for this indication. NK-1 RA have been studied for prevention of PONV in abdominal and gynecological surgery and found to be effective but no literature is available regarding its use in breast cancer patient.  Considering the fact that breast cancer patients are at high risk of PONV, we planned this study of Aprepitant versus Dexamethasone for Preventing Postoperative Nausea and Vomiting in Breast Cancer Patients undergoing surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study Completion: 2018-07-31
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable will be episodes of nausea and or vomiting in the early and late postoperative period in first 24 hours	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 Measures

Name	Time	Method
The incidence of any adverse reaction to treatment in the two experimental groups will be recorded	till discharge

Trial Locations

Locations (1)

DR BRA IRCH,All India Institute of Medical Sciences; 🇮🇳 West, DELHI, India

DR BRA IRCH,All India Institute of Medical Sciences

🇮🇳West, DELHI, India

Dr Sachidanand Jee Bharati

Principal investigator

011-29575101

sachidadr@yahoo.co.in