Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

Study Overview
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Brief Summary
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BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy. METHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.

Official Title
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Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy

Conditions
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Lidocaine, Dexmedetomidine, Quality of Recovery(QoR-40), Preoperative and Postoperative

Intervention / Treatment
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* Drug: Co-administration Lidocaine and Dexmedetomidine
* Drug: Dexmedetomidine infusion
* Drug: Lidocaine infusion
* Drug: Saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ Scheduled for elective laparoscopic total 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
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery<br> | Drug: Co-administration Lidocaine and Dexmedetomidine<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.<br>Drug: Lidocaine infusion<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.<br>Drug: Saline infusion<br>* Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.<br>|
| Experimental: Effect of Dexmedetomidine infusion on Quality of Recovery<br> | Drug: Co-administration Lidocaine and Dexmedetomidine<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.<br>Drug: Lidocaine infusion<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.<br>Drug: Saline infusion<br>* Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.<br>|
| Experimental: Effect of Lidocaine infusion on Quality of Recovery<br> | Drug: Co-administration Lidocaine and Dexmedetomidine<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.<br>Drug: Lidocaine infusion<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.<br>Drug: Saline infusion<br>* Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.<br>|
| Experimental: Effect of saline infusion on Quality of Recovery<br> | Drug: Co-administration Lidocaine and Dexmedetomidine<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.<br>Drug: Dexmedetomidine infusion<br>* Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.<br>Drug: Lidocaine infusion<br>* Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.<br>Drug: Saline infusion<br>* Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery scores(QoR-40) | Our primary outcome was Quality of recovery scores(QoR-40) 1 day after operation | 1 day after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative remifentanil total dose | Secondary Outcome Measure was remifentanil total dose during the perioperative period | Intraoperative | 
| Recovery time | Secondary Outcome Measure was recovery time | Immediately after the surgery | 
| Extubation time | Secondary Outcome Measure was extubation time | Immediately after the surgery | 
| Pain visual analogue scale scores | Secondary Outcome Measure was pain visual analogue scale scores | The first 24 hours after operation | 
| PONV scores | Secondary Outcome Measure was PONV scores | The first 24 hours after operation | 
| The consumption of sufentanil | Secondary Outcome Measure was consumption of sufentanil | The first 24 hours after operation | 
| The length of post-anesthesiacare unit stay | Secondary Outcome Measure was the length of post-anesthesiacare unit stay | Immediately after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Dexmedetomidine, Quality of recovery