Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

Overview

Mirtazapine is a noradrenergic and specific serotonergic antidepressant. Its antagonist at the 5HT3 receptor may help to prevent nausea and vomiting. The use of mirtazapine in the management of nausea and vomiting has been reported in the literature, both for treatment and premedication. Dexamethasone, possesses analgesic, anti-inflammatory, immune-modulating, and antiemetic effects. Dexamethasone was reported to be effective in preventing nausea and vomiting in patients receiving cancer chemotherapy. It has also been shown to be effective in reducing nausea and vomiting after open and laparoscopic surgical procedures. In this randomized controlled trial, we will compare the effectiveness of both drugs in preventing PONV in laparoscopic cholecystectomy surgery.

Full Title of Study: “Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting After Lap Cholecystectomy a Comparative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 28, 2023

Detailed Description

this double-blinded randomized study will be conducted at Ain-Shams university hospitals. Patients are aged 21-60 years and body weight 60-100 Kg of the American Society of Anaesthesiologists (ASA) physical status I or II scheduled for laparoscopic cholecystectomy under general anesthesia will be enrolled in this study., patients will be randomly divided into 2 equal groups; The M(Mirtazapine) group:(n=45) each patient will receive an oral disintegrating tablet (ODT) of mirtazapine 30 mg with sips of water and 100 ml 0.9% sodium chloride (normal saline [NS]) (IVI) over 15 min as a placebo 1 h preoperatively. The D (Dexamethasone) group: (n=45) each patient will receive a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 min, 1 h preoperatively. standard monitoring in the form of (ECG, pulse oximeter, NIBP, peripheral temperature monitoring) will be attached to all patients and capnography will be connected after intubation. baseline measures will be recorded, and subsequent values will be recorded every 15 min. Patients will be observed for 24 hours postoperative. And the following will be recorded; Time to awakening (time from the end of anesthesia until the patients opened their eyes on command) and Time to the first analgesia. Patients´ vital data (BP, HR, RR, O2 saturation) will be monitored every 15 minutes for the first postoperative hour, then every 4 hours. Postoperative pain will be assessed every 4 hours with a 10-cm visual analog scale VAS (0=no pain to 10=most severe pain) score. The incidence of occurrence of postoperative Nausea and vomiting will be evaluated every 4 hours on a two-point verbal scale (0, none; 1, nausea or vomiting). The severity of nausea and vomiting will be assessed using a verbal numerical rating scale from 0 = no nausea/ vomiting and 10 = nausea/ vomiting as bad as it could be.The complete response is defined as no nausea, no vomiting, and no antiemetic medication during a 24-h postoperative period

Interventions

  • Drug: Mirtazapine 30 MG
    • mirtazapine is given in arm M to prevent PONV
  • Drug: Dexamethasone
    • Dexamethasone is given in arm D to prevent PONV

Arms, Groups and Cohorts

  • Active Comparator: Group M: patients receive Mirtazapine
    • the patient will receive an oral disintegrating tablet (ODT) of mirtazapine 30 mg with sips of water and 100 ml 0.9% sodium chloride (normal saline [NS]) (IVI) over 15 min as a placebo 1 h preoperatively
  • Active Comparator: Group D: patients receive Dexamethasone
    • the patient will receive a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 min, 1 h preoperatively.

Clinical Trial Outcome Measures

Primary Measures

  • the incidence and severity of nausea and vomiting
    • Time Frame: 24 hours postoperative
    • compare the effectiveness of Mirtazapine and Dxamethasone in decreasing the incidence of PONV

Secondary Measures

  • occurrence of postoperative complications related to the study drugs.
    • Time Frame: 24 hours postoperative
    • any drug related complication

Participating in This Clinical Trial

Inclusion Criteria

  • ASA physical status I or II – body weight 60-100 Kg – scheduled for laparoscopic cholecystectomy under general anaesthesia Exclusion Criteria:

  • Patient's refusal to participate in the study, – Obesity with body mass index (BMI) >35 kg/m2, – Physical status: ASA III or above, – Patients with a history of PONV, motion sickness, or major systemic diseases – Patients who received an antiemetic drug within 48 h before surgery, – Patients facing liver or kidney problems with a high level of BUN or serum creatinine, – A history of allergy to the study drugs. – Pregnant, lactating, or menstruating patients

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rania Maher Hussien, MD, Lecturer of Anaesthesia and intensive care – Ain Shams University
  • Overall Official(s)
    • Rania Hussien, MD, Principal Investigator, Lecturer of Anaesthesia, Ain Shams University
  • Overall Contact(s)
    • Rania Hussien, MD, 01000544520, raniamhm@yahoo.com

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