Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV

Not Applicable

Completed

• Conditions: Lidocaine; Dexmedetomidine; Nausea and Vomiting, Postoperative
• Interventions: Drug: lidocaine and dexmedetomidine IV; Drug: saline IV

• Registration Number: NCT03788018
• Lead Sponsor: Xu Siqi

Brief Summary

BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.

METHODS: One hundred and twenty women with elective laparoscopic hysterectomy were randomly divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON group, n=60) received the equal volume of saline. Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-11-15
• Study Completion: 2018-12-01
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
• Aged 40-55 years
• Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria

• History of allergy to local anesthetics
• Severe respiratory disease
• Renal or hepatic insufficiency
• History of preoperative opioids medication and psychiatric
• preoperative bradycardia
• preoperative atrioventricular block
• Subjects who experienced severe hypotension (mean arterial pressure [MAP] <60 mmHg) or bradycardia (heart rate [HR] <40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effect of IV lidocaine and dexmedetomidine on PONV	lidocaine and dexmedetomidine IV	-
Effect of IV saline on PONV	saline IV	-
Effect of IV saline on PONV	lidocaine and dexmedetomidine IV	-
Effect of IV lidocaine and dexmedetomidine on PONV	saline IV	-

Primary Outcome Measures

Name	Time	Method
postoperative nausea	24-48 hours after surgery	Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting	24-48 hours after surgery	Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
postoperative nausea and vomiting (PONV)	24-48 hours after surgery	Our primary outcome was the incidence of PONV during the 24-48 hours after surgery

Trial Locations

Locations (1)

Department of Anqing Hospital Anesthesiology; 🇨🇳 Anqing, Anhui, China