Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

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

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

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting
• Intervention / Treatment: Drug: tropisetron; Drug: metoclopramide; Drug: dexamethasone; Other: normal saline

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Guangyou Duan, MD; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tropisetron; Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.	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.
Experimental: metoclopramide; Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.	Drug: 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.
Experimental: dexamethasone; Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.	Drug: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Guangyou Duan, MD, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: tramadol; nausea and vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Serotonin 5-HT3 Receptor Antagonists; Dexamethasone; Metoclopramide; Tropisetron
• Other Study ID Numbers: Nausea and vomiting

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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