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NCT Number: NCT04547842

Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain Shams University

Cairo, Abassia, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirtazapine 30 MG

Drug

mirtazapine is given in arm M to prevent PONV

Other names: Remeron

Dexamethasone

Drug

Dexamethasone is given in arm D to prevent PONV

Other names: Decadrone

Primary outcomes

  1. 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 outcomes

  1. occurrence of postoperative complications related to the study drugs.

    Time frame: 24 hours postoperative

    any drug related complication

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting After Lap Cholecystectomy a Comparative Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2020
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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