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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
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
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 modified 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Midazolam Drug: Dexamethasone, ondansetron Not Applicable

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Masking Description: concealed envelopes
Primary Purpose: Prevention
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


Arm Intervention/treatment
Active Comparator: Group A
Dexamethasone-ondansetron
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
Midazolam
Drug: Midazolam
2 mg of injection midazolam intravenous 30 minutes prior to the end of surgery versus a combination of dexamethasone and ondansetron




Primary Outcome Measures :
  1. Postoperative nausea vomiting [ Time Frame: 24 hours ]
    the incidence of postoperative nausea and/or vomiting within first 24 hours postoperatively


Secondary Outcome Measures :
  1. Rescue antiemetic [ Time Frame: 24 hours ]
    The amount of antiemetic used within the first 24 hours.

  2. Time to achieve PADSS>9 [ Time Frame: 1 hour ]
    Time taken to achieve a Post anaesthesia discharge score of ≥9



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients more than 18 years of age
  • Patients belonging to ASA-PS (American society of anesthesiologists Physical status) 1 or 2
  • Patients with 3 or more risk factors for developing PONV undergoing laparoscopic surgeries

Exclusion Criteria:

  • Anticipated difficult airway
  • Obesity (body mass index >30 kg.m2),
  • Pregnancy
  • Patients with ASA - PS more than 2
  • Consumption of an agent with anti-emetic properties within 24 h prior to commencement of the study.
  • Known hypersensitivity to midazolam, ondansetron or dexamethasone
  • Patients not giving consent.
  • Patients with psychiatric illness or mental retardation

Information from the National Library of Medicine

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


Contacts
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Contact: Kelika Prakash, DM +919540947117 kelika.prakash@gmail.com

Locations
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India
Institute of Liver and Biliary scienecs Recruiting
New Delhi, Delhi, India, 110067
Contact: Kelika Prakash, DM         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Kelika Prakash, DM Institute of liver and biliary sciences

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03603119     History of Changes
Other Study ID Numbers: PONV prophylaxis
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Liver and Biliary Sciences, India:
Postoperative Nausea and Vomiting
Dexamethasone
Ondansetron
Midazolam
Laparoscopy
High risk

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Ondansetron
BB 1101
Midazolam
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents