Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting for Laparoscopic Surgeries

NCT03603119 | Completed

• 1 other identifier: PONV prophylaxis
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting; Dexamethasone; Ondansetron; Midazolam; Laparoscopy; High risk

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea vomiting

  the incidence of postoperative nausea and/or vomiting within first 24 hours postoperatively

  24 hours

Secondary Outcomes (3)

• Rescue antiemetic

  24 hours

• Time to achieve PADSS>9

  1 hour

• Incidence of PON, POV, PONV at 2 hours and PON and POV at 24

  24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Dexamethasone-ondansetron

Drug: Dexamethasone, ondansetron

Group B

EXPERIMENTAL

Midazolam

Drug: Normal saline, Midazolam

Interventions

Normal saline, Midazolam DRUG

2 cc normal saline i.v. after anaesthesia induction.2 mg of injection midazolam intravenous 30 minutes prior to the end of surgery

Group B

Dexamethasone, ondansetron DRUG

8mg of dexamethasone i.v. after anaesthesia induction and 4 mg of ondansetron i.v. 30 minutes prior to the end of surgery.

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Saline Solution; Midazolam; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Kelika Prakash, DM

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: concealed envelopes
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 27, 2018
• Study Start: May 1, 2018
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

IN (1)