Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV

Study Overview
=================
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.

Official Title
-----------------
Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy

Conditions
-----------------
Lidocaine, Dexmedetomidine, Nausea and Vomiting, Postoperative

Intervention / Treatment
-----------------
* Drug: lidocaine and dexmedetomidine IV
* Drug: saline IV


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effect of IV lidocaine and dexmedetomidine on PONV<br> | Drug: lidocaine and dexmedetomidine IV<br>* Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.<br>Drug: saline IV<br>* Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery<br>|
| Experimental: Effect of IV saline on PONV<br> | Drug: lidocaine and dexmedetomidine IV<br>* Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.<br>Drug: saline IV<br>* Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea | Our primary outcome was the incidence of nausea during the 0-2 hours after surgery | 0-2 hours after surgery | 
| postoperative nausea | Our primary outcome was the incidence of nausea during the 2-24 hours after surgery | 2-24 hours after surgery | 
| postoperative nausea | Our primary outcome was the incidence of nausea during the 24-48 hours after surgery | 24-48 hours after surgery | 
| postoperative vomiting | Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery | 0-2 hours after surgery | 
| postoperative vomiting | Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery | 2-24 hours after surgery | 
| postoperative vomiting | Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery | 24-48 hours after surgery | 
| postoperative nausea and vomiting (PONV) | Our primary outcome was the incidence of PONV during the 0-2 hours after surgery | 0-2 hours after surgery | 
| postoperative nausea and vomiting (PONV) | Our primary outcome was the incidence of PONV during the 2-24 hours after surgery | 2-24 hours after surgery | 
| postoperative nausea and vomiting (PONV) | Our primary outcome was the incidence of PONV during the 24-48 hours after surgery | 24-48 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy