Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting for Laparoscopic Surgeries
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|ClinicalTrials.gov Identifier: NCT03603119|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: Midazolam Drug: Dexamethasone, ondansetron||Not Applicable|
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 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Masking Description:||concealed envelopes|
|Official Title:||A Comparison of Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting in High Risk Patients Undergoing Laparoscopic Surgeries|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Active Comparator: Group A
Drug: Dexamethasone, ondansetron
8mg of dexamethasone i.v. after anaesthesia induction and 4 mg of ondansetron i.v. 30 minutes prior to the end of surgery.
Experimental: Group B
2 mg of injection midazolam intravenous 30 minutes prior to the end of surgery versus a combination of dexamethasone and ondansetron
- Postoperative nausea vomiting [ Time Frame: 24 hours ]the incidence of postoperative nausea and/or vomiting within first 24 hours postoperatively
- Rescue antiemetic [ Time Frame: 24 hours ]The amount of antiemetic used within the first 24 hours.
- Time to achieve PADSS>9 [ Time Frame: 1 hour ]Time taken to achieve a Post anaesthesia discharge score of ≥9
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603119
|Contact: Kelika Prakash, DMfirstname.lastname@example.org|
|Institute of Liver and Biliary scienecs||Recruiting|
|New Delhi, Delhi, India, 110067|
|Contact: Kelika Prakash, DM|
|Principal Investigator:||Kelika Prakash, DM||Institute of liver and biliary sciences|