1. Comparison of Ondansetron and Dexamethasone versus Dexamethasone efficacy on postoperative nausea and vomiting in patients with maxillofacial trauma
2. Determining the frequency of nausea and vomiting in the intervention group and control group
3. Comparison of the frequency of nausea and vomiting in the intervention group and control by gender, age groups, duration of anesthesia and duration of surgery.
Design
Phase 1 triple-blind clinical trial with control group and one intervention group, and randomized by block randomization, is performed on 96 patients.
Settings and conduct
Patients are selected according to inclusion and exclusion criteria until the study is completed. The same treatment protocol is performed for all patients. Except that at the end of surgery for the intervention group, 8mg ondansetron IV is injected.
Participants/Inclusion and exclusion criteria
All patients referred to "Shohadaye Ashayer" hospital who have maxillofacial trauma and require surgery under general anesthesia are included. All patients who underwent another operation under general anesthesia 24 hours before maxillofacial surgery will be excluded from our study. Also patients with a history of Motion Sickness and recent vomiting, patients who are hypersensitive or allergic to any of the drugs studied, patients who have undergone surgery for severe hypotension and bradycardia, and need intraoperative blood transfusion or postoperative ICU They are out of action, they will be out of our study.
Intervention groups
At the end of surgery for the intervention group, ondansetron 8 mg will be injected through IV. No medication will be injected for the control group at the end of surgery.
Main outcome variables
Achieving the desired results means reducing nausea and vomiting without using additional drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190916044784N2
Registration date:2023-05-25, 1402/03/04
Registration timing:prospective
Last update:2023-05-25, 1402/03/04
Update count:0
Registration date
2023-05-25, 1402/03/04
Registrant information
Name
Shahryar Bashirigoudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4415 7941
Email address
dr.s.bashiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ondansetron and Dexamethasone Versus Dexamethasone efficacy On Postoperative nausea and vomiting in patients with maxillofacial trauma
Public title
Comparison of Ondansetron and Dexamethasone Versus Dexamethasone efficacy On Postoperative nausea and vomiting in patients with maxillofacial trauma refered to "Shohadaye Ashayer" hospital of Khorramabad
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred to the "Shohadaye Ashayer" Hospital who have maxillofacial trauma and require surgery under general anesthesia.
Exclusion criteria:
Patients who underwent another operation under general anesthesia 24 hours before maxillofacial surgery.
Patients who have lost consciousness for any reason after trauma.
Patients with ASA≥III.
Patients with a history of Motion sickness or recent vomiting.
Patients who have severe hypotension and bradycardia while surgery, and need intraoperative blood transfusion or postoperative ICU.
Patients with hypersensitivity or allergy to any of the studied drugs.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In order to equalize the production of individuals in the two groups, the Block Randomization method is used. Using this method, the sample size in the two study arms will be equal (balance).
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the study, the severity of postoperative nausea and vomiting of patients is assessed by a person who is not aware of the study groups. Also, the patient and the person analyzing the study information are not aware of the drug injected for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Lorestan School of Dentistry, Between Golshan 1,2 Ave., Shafipour Blvd.
City
Khorramabad
Province
Lorestan
Postal code
6816844168
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.LUMS.REC.1401.001
Health conditions studied
1
Description of health condition studied
Maxillofacial trauma
ICD-10 code
S02
ICD-10 code description
Fracture of skull and facial bones
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
1, 2, 6, 12 and 24 hours after surgery
Method of measurement
Direct questions from patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: For all the studied patients, after entering the operating room (both the intervention group and the control group), an IV line will be installed. In order to prevent dehydration of patients, 500 cc of Ringer's serum is injected for each patient. Then, for all patients, pre-medication with midazolam in the amount of 2-3 mg and narcotic (fentanyl) in the amount of 2-4 cc (depending on the weight of the people) is done. After 3-5 minutes, induction of anesthesia begins. In all patients, propofol at the rate of 2-2.5 mg/kg, and atrocurium at the rate of 2.5 mg/kg as a muscle relaxant are used to induce anesthesia. Before surgery and during induction of anesthesia, 8 mg of dexamethasone is injected as an IV injection for all patients (whether in the intervention or control group). All subjects undergo nasal intubation 2-4 minutes after induction of anesthesia and injection of relaxant. After intubation, all people are connected to a mechanical ventilator. During surgery, anesthesia is maintained in all patients through TIVA and propofol will be injected at the rate of 0.1 mg/kg/minute. During the surgery, depending on the patient's needs (once every 35-45 minutes), the muscle relaxant will be repeated at the rate of 0.2 mg/kg. All patients are transferred to the recovery room after surgery, and the amount of nausea and vomiting as well as their possible side effects are recorded at intervals of 1, 2, 6, 12 and 24 hours after surgery. At the end of surgery, 8 mg of ondansetron is injected through IV injection for the intervention group.
Category
Prevention
2
Description
Control group: For the control group, no medicine is prescribed in addition to what was proposed as the main study protocol. After surgery, dexamethasone is injected for all patients on the first day at the rate of 2 doses per day and on the second day at the rate of 1 dose per day. In order to prevent disturbances in the treatment process of the patients, if nausea and vomiting of any of the patients (including from intervention and control group) was higher than one level, intervention and drug administration will be done to reduce or eliminate nausea and vomiting. This topic will be recorded in the questionnaire and study information.