Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04547842

Collaborator

(none)

Enrollment

Location

Arms

27.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Nausea and Vomiting	Drug: Mirtazapine 30 MG Drug: Dexamethasone	Early Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 preoperativelypatients 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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 28, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Mirtazapine 30 MG mirtazapine is given in arm M to prevent PONV Other Names: Remeron
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.	Drug: Dexamethasone Dexamethasone is given in arm D to prevent PONV Other Names: Decadrone

Arm

Intervention/Treatment

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

Drug: Mirtazapine 30 MG

mirtazapine is given in arm M to prevent PONV

Other Names:

Remeron

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.

Drug: Dexamethasone

Dexamethasone is given in arm D to prevent PONV

Other Names:

Decadrone

Outcome Measures

Primary Outcome Measures

the incidence and severity of nausea and vomiting [24 hours postoperative]
compare the effectiveness of Mirtazapine and Dxamethasone in decreasing the incidence of PONV

Secondary Outcome Measures

occurrence of postoperative complications related to the study drugs. [24 hours postoperative]
any drug related complication

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Abassia	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Rania Hussien, MD, Lecturer of Anaesthesia, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rania Maher Hussien, MD, Lecturer of Anaesthesia and intensive care, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04547842

Other Study ID Numbers:

FMASU R 48 / 2020

First Posted:

Sep 14, 2020

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Nausea

Vomiting

Postoperative Nausea and Vomiting

Dexamethasone

Mirtazapine

Study Results

No Results Posted as of Aug 5, 2022