Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533281
• Other study ID #: Nausea and vomiting
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2022
• Est. completion date: November 3, 2023

Study information

• Verified date: December 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 3, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Drug:
• tropisetron
One tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.
• metoclopramide
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.
• dexamethasone
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.

Other:
• normal saline
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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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