Postoperative Nausea and Vomiting Clinical Trial
Official title:
A Comparison of Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting in High Risk Patients Undergoing Laparoscopic Surgeries
Postoperative nausea and vomiting(PONV) affects 11 to 60 % of patients undergoing surgery and is a major cause of postoperative morbidity. Risk factors include female gender, non smokers, postoperative use of opioids and a past history of PONV. The simplified Apfel risk score is used to identify patients at risk for PONV. PONV prophylaxis is provided intraoperatively to patients with 2 or more risk factors. In spite of numerous drugs available, control of PONV remains a difficult task. Midazolam is a commonly used drug perioperatively for its anxiolytic and sedative properties. It decreases analgesic requirement and has also been found to have an antiemetic effect. This present study is designed to compare the prophylactic use of iv midazolam with a commonly used combination of dexamethasone-ondansetron in high risk patients (as defined by the modified Apfel score) undergoing laparoscopic surgeries.
After Institutional Ethical Committee approval and written informed consent, 120 adult
patients will be recruited for the study if they satisfy the inclusion and exclusion criteria
as mentioned later. Consent will be obtained from the patients themselves. Standard protocol
for administration of anaesthesia will be followed in all patients which is briefly
described. All patients will receive general anaesthesia and will be induced with Propofol
titrated to effect. Intraoperatively, isoflurane will be used as maintenance agent and
vecuronium or atracurium as non depolarizing muscle relaxant. For analgesia, patients will
receive intraoperative fentanyl.
For the purpose of the study, patients will be randomized into two groups depending upon a
computer generated randomized sheet. Group A will receive 8mg of dexamethasone i.v. after
anaesthesia induction and 4 mg of ondansetron i.v. 30 minutes prior to the end of surgery.
Patients in Group B will be administered 2 mg of midazolam i.v. 30 minutes prior to the end
of surgery. Time to achieve Post anaesthesia discharge score( PADSS) of ≥9 will be noted.
Patients will be asked to report any incidence of nausea, retching or vomiting for the first
24 hours after surgery. The incidence of PONV and the amount of rescue antiemetic received
will be noted at 2 hours and at 24 hours postoperatively. PONV will be scored based on the
PONV Impact Scale score questionnaire (mentioned in the proforma)12. Rescue antiemetics will
be administered in case the patient complains of PONV in accordance with American society of
anesthesiologists (ASA) guidelines. The first line of rescue in Group A will be 10 mg of iv
metaclopromide. Antihistaminics will be the second line of rescue antiemetic. In group B the
first line of antiemetic will be 4 mg of ondansetron i.v. 10 mg of iv metaclopromide will be
second line of rescue drug.
Study period : It is estimated that the study will be completed within one year Sample size
Assuming a reduction in 45 % in the incidence of PONV, with α error of 0.05 and β of 0.02, we
would require 60 patients in each group i.e. a total of 120 patients.13 Intervention: For
administration of PONV prophylaxis, patients will be randomized into two groups depending
upon a computer generated randomized sheet. Group A will receive 8mg of dexamethasone i.v.
after anaesthesia induction and 4 mg of ondansetron i.v. 30 minutes prior to the end of
surgery. Patients in Group B will be administered 2 mg of midazolam i.v. 30 minutes prior to
the end of surgery.
Monitoring and assessment: Patients will be monitored 24 hours post operatively. Any
complaints of nausea and/vomiting will be noted and rescue antiemetic will be administered as
per the guidelines
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