Post Operative Nausea and VomitingEarly Phase 1NCT04547842
Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting
A Early Phase 1 study testing Mirtazapine 30 MG and Dexamethasone in people with Post Operative Nausea and Vomiting, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Nausea and Vomiting
- What is being tested?
- Mirtazapine 30 MG and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Jul 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I or II
- body weight 60-100 Kg
- scheduled for laparoscopic cholecystectomy under general anaesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting After Lap Cholecystectomy a Comparative Study
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.
Read the 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
- Conditions
- Post Operative Nausea and Vomiting
- Being tested
- Mirtazapine 30 MG, Dexamethasone
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine 30 MGDrug
Also called Remeron
mirtazapine is given in arm M to prevent PONV
DexamethasoneDrug
Also called Decadrone
Dexamethasone is given in arm D to prevent PONV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence and severity of nausea and vomiting
compare the effectiveness of Mirtazapine and Dxamethasone in decreasing the incidence of PONV
Measured: 24 hours postoperative
Secondary outcomes (1)
occurrence of postoperative complications related to the study drugs.
any drug related complication
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Sep 2020
- Primary completion28 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 preoperatively
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
- Investigators
- Rania Hussien, MD, Principal investigator, Lecturer of Anaesthesia, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547842
- Sponsor's protocol ID
- FMASU R 48 / 2020
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2020
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting After Lap Cholecystectomy a Comparative Study
- ClinicalTrials.gov ID
- NCT04547842
- Acronym / sponsor ID
- FMASU R 48 / 2020
- Conditions
- Post Operative Nausea and Vomiting
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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 preoperatively
| Arm | Type | Receives |
|---|---|---|
| Group M: patients receive Mirtazapine | Active comparator | Drug: Mirtazapine 30 MGthe 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 |
| Group D: patients receive Dexamethasone | Active comparator | Drug: Dexamethasonethe 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I or II
- body weight 60-100 Kg
- scheduled for laparoscopic cholecystectomy under general anaesthesia
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine 30 MGAlso: Remeronmirtazapine is given in arm M to prevent PONV | Drug | Group M: patients receive Mirtazapine |
| DexamethasoneAlso: DecadroneDexamethasone is given in arm D to prevent PONV | Drug | Group D: patients receive Dexamethasone |
Primary outcome
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
1 secondary outcome
occurrence of postoperative complications related to the study drugs.
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Hussien, MD principal investigator
Lecturer of Anaesthesia, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mirtazapine 30 MG and Dexamethasone in people with Post Operative Nausea and Vomiting, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence and severity of nausea and vomiting (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.