Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Study Overview
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Brief Summary
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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: Two hundred and forty women with elective laparoscopic hysterectomy were randomly divided into four groups: the control group (group C, n=60) received an equal volume of saline, the lidocaine group (group L, n=60) received IV lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group D, n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group LD, n=60) received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion). 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
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Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia

Conditions
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Lidocaine, Dexmedetomidine, Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: lidocaine and dexmedetomidine infusion
* Drug: Saline infusion
* Drug: Lidocaine infusion
* Drug: Dexmedetomidine infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ Aged 40-60 years Scheduled for elective laparoscopic hysterectomy Exclusion Criteria: History of allergy to local anesthetics BMI>30 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
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV<br> | Drug: lidocaine and dexmedetomidine infusion<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 infusion<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>Drug: Lidocaine infusion<br>* patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.<br>* Other names: Dexmedetomidine;|
| Experimental: Effect of infusion saline on PONV<br> | Drug: lidocaine and dexmedetomidine infusion<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 infusion<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>Drug: Lidocaine infusion<br>* patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.<br>* Other names: Dexmedetomidine;|
| Experimental: Effect of infusion lidocaine on PONV<br> | Drug: lidocaine and dexmedetomidine infusion<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 infusion<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>Drug: Lidocaine infusion<br>* patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.<br>* Other names: Dexmedetomidine;|
| Experimental: Effect of infusion dexmedetomidine on PONV<br> | Drug: lidocaine and dexmedetomidine infusion<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 infusion<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>Drug: Lidocaine infusion<br>* patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.<br>* Other names: Dexmedetomidine;|

What is the study measuring?
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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
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy