Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

Study Overview
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Brief Summary
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To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection

Official Title
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Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting

Conditions
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Nausea and Vomiting

Intervention / Treatment
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* Drug: tropisetron
* Drug: metoclopramide
* Drug: dexamethasone
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists classification I-II 18.5≤BMI≤28 Patients who require general anesthesia and receive PCIA Voluntarily and be able to understand and sign the informed consent form Exclusion Criteria: Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history History of allergy to opioids Patients with a history or family history of epilepsy that has not been controlled by treatment Sedatives and antidepressants were used 24 hours before surgery Failure to cooperate with the study for any reason or in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tropisetron<br>Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed within 1min. | Drug: tropisetron<br>* One tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed within 1min.<br>|
| Experimental: metoclopramide<br>Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min. | Drug: metoclopramide<br>* One dose of metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.<br>|
| Experimental: dexamethasone<br>Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min. | Drug: dexamethasone<br>* One dose of dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.<br>|
| Placebo Comparator: normal saline<br>Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously within one minute to ensure constant speed. | Other: normal saline<br>* Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score of nausea and vomiting | NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable) | From before administration to 10min after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting | PONV is recorded according to whether the patient present nausea and vomiting during the follow-up visits after surgery | From end of operation to 24 hours after operation | 
| NRS score of postoperative nausea and vomiting | NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable) | From end of operation to 24 hours after operation | 
| Incidence of extra treatment for postoperative nausea and vomiting | Incidence of extra treatment for postoperative nausea and vomiting was assessed by whether patient using other treatment for postoperative nausea and vomiting during the the follow-up visits after surgery | From end of operation to 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tramadol, nausea and vomiting