Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

Post Operative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547842
• Other study ID #: FMASU R 48 / 2020
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: Rania Hussien, MD
• Phone: 01000544520
• Email: raniamhm[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 30, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Post Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	occurrence of postoperative complications related to the study drugs.	any drug related complication	24 hours postoperative