Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

Phase 4

Completed

• Conditions: Nausea and Vomiting
• Interventions: Other: normal saline; Drug: metoclopramide; Drug: tropisetron; Drug: dexamethasone

• Registration Number: NCT05533281
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Study Start: 2022-09-15
• Status Verified: 2022-12
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-03
• Last Update Submitted: 2024-03-31
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• American Society of Anesthesiologists classification I-II
• 18.5≤BMI≤28
• Patients who receiving breast and thyroid surgery and requiring 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously to ensure constant speed.
metoclopramide	metoclopramide	Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
tropisetron	tropisetron	Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.
dexamethasone	dexamethasone	Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China