Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

NCT04547842 | Completed Early Phase 1

• 1 other identifier: FMASU R 48 / 2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• the incidence and severity of nausea and vomiting

  compare the effectiveness of Mirtazapine and Dxamethasone in decreasing the incidence of PONV

  24 hours postoperative

Secondary Outcomes (1)

• occurrence of postoperative complications related to the study drugs.

  24 hours postoperative

Study Arms (2)

Group M: patients receive Mirtazapine

ACTIVE COMPARATOR

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

Drug: Mirtazapine 30 MG

Group D: patients receive Dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Interventions

Mirtazapine 30 MG DRUG

mirtazapine is given in arm M to prevent PONV

Also known as: Remeron

Group M: patients receive Mirtazapine

Dexamethasone DRUG

Dexamethasone is given in arm D to prevent PONV

Also known as: Decadrone

Group D: patients receive Dexamethasone

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abassia, Egypt

Location

MeSH Terms

Conditions

Vomiting

Interventions

Mirtazapine; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Rania Hussien, MD

  Lecturer of Anaesthesia, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done using computer-generated number table of random numbers in a 1:1 ratio in opaque and sealed envelope (SNOSE). The assigned treatment will be written on a card and sealed in opaque envelopes consecutively numbered. These envelopes will be opened just immediately before administering the medication in the patient's room. The study drugs will be prepared by the hospital pharmacy and the patients, follow-up will be conducted by an anaesthesia resident who is not involved in any other part of the study.The patients and the investigators who collected the data will be blinded to the patient's group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anaesthesia and intensive care

Model Details: 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 (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

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: September 1, 2020
• Primary Completion: July 28, 2023
• Study Completion: July 30, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

EG (1)