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Clinical Trials/CTRI/2021/04/032750
CTRI/2021/04/032750Not yet recruitingNot Applicable

Efficacy of combining midazolam vs dexamethasone with ondansetron for prevention of Postoperative Nausea and Vomiting among women undergoing emetogenic surgeries - A randomised control trial

Bangalore Baptist hospital1 site in 1 country124 target enrollmentStarted: June 3, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
124
Locations
1
Primary Endpoint
To compare the effectiveness of Midazolam and Ondansetron Vs Dexamethasone and Ondansetron in prophylaxis of Post operative Nausea Vomiting in female patients undergoing emetogenic surgeries.

Study Overview

Brief Summary

Postoperative nausea and vomiting (PONV) occurs in 20–30% of surgeries in the general population and in up to 70% of high risk patients within the first 24 hours after surgery.

Routinely, the simplified risk score by Apfel et al is used to predict the risk of PONV in adult patients. The strongest predictive factors for PONV are female sex, non-smoking status, history of PONV or motion sickness and postoperative use of opioids.Surgical procedures such as cholecystectomy, gynaecological surgery, breast surgeries, middle ear surgeries and laparoscopic approach are associated with a higher incidence of PONV when compared with general surgery as a reference group and such surgeries are now considered as independent risk factor for PONV.In this study we are considering 2 risk factors – Female gender and Surgical risk factor ie. type of surgery.

Combination therapy for PONV prophylaxis is preferable to using a single drug alone6,4. Apfel et al. demonstrated that the effects of antiemetics acting on different receptors are additive. Therefore adults at moderate and high risk for PONV should receive combination therapy with drugs from different classes.

In this study we aim to compare the efficacy of midazolam when combined with ondansetron, against the most widely used combination of dexamethasone and ondansetron.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Laparoscopic surgeries Middle ear surgeries Gynaecological surgeries Breast surgeries Cholecystecomies BMI <34.9 kg/m2.

Exclusion Criteria

  • •Smokers Pregnant/lactating women Use of nitrous oxide intraoperatively Patients having history of motion sickness/ PONV Patients on chronic steroid therapy Patients on chronic opiod analgesics Patients on preoperative chemotherapy Patients who receive antiemetic/steroid 24 hrs prior to commencement of study Patients suffering from diabetes mellitus with autonomic neuropathy, intestinal obstruction, hiatus hernia, hepatic and renal diseases Patients with neurological diseases/ Neuromuscular diseases Patients with prolonged QTC interval Patients on CNS depressant drugs Patients with psychiatric illness or cognitive impairment.

Outcomes

Primary Outcomes

To compare the effectiveness of Midazolam and Ondansetron Vs Dexamethasone and Ondansetron in prophylaxis of Post operative Nausea Vomiting in female patients undergoing emetogenic surgeries.

Time Frame: 24 hrs

Secondary Outcomes

  • 1.Total dose of rescue antiemetic required(2.Total episodes of Nausea and Vomiting)

Investigators

Sponsor Class
Private hospital/clinic

Study Sites (1)

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