Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting
Primary Purpose
Post Operative Nausea and Vomiting
Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Mirtazapine 30 MG
Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Nausea and Vomiting
Eligibility Criteria
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
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group M: patients receive Mirtazapine
Group D: patients receive Dexamethasone
Arm Description
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
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.
Outcomes
Primary Outcome Measures
the incidence and severity of nausea and vomiting
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.
any drug related complication
Full Information
NCT ID
NCT04547842
First Posted
September 8, 2020
Last Updated
February 13, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04547842
Brief Title
Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting
Official Title
Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting After Lap Cholecystectomy a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group M: patients receive Mirtazapine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group D: patients receive Dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mirtazapine 30 MG
Other Intervention Name(s)
Remeron
Intervention Description
mirtazapine is given in arm M to prevent PONV
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadrone
Intervention Description
Dexamethasone is given in arm D to prevent PONV
Primary Outcome Measure Information:
Title
the incidence and severity of nausea and vomiting
Description
compare the effectiveness of Mirtazapine and Dxamethasone in decreasing the incidence of PONV
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
occurrence of postoperative complications related to the study drugs.
Description
any drug related complication
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Hussien, MD
Phone
01000544520
Ext
202
Email
raniamhm@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fathy Tash, MD
Phone
26857539
Ext
202
Email
fathytash@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Hussien, MD
Organizational Affiliation
Lecturer of Anaesthesia, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abassia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fathy Tash, MD
Phone
26857539
Ext
202
Email
fathytash@yahoo.com
12. IPD Sharing Statement
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Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting
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