Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
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| ClinicalTrials.gov Identifier: NCT03809923 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2019
Last Update Posted : January 13, 2021
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Sponsor:
Anqing Municipal Hospital
Information provided by (Responsible Party):
Anqing Municipal Hospital
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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: 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=40) 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lidocaine Dexmedetomidine Nausea and Vomiting, Postoperative | Drug: lidocaine and dexmedetomidine infusion Drug: Saline infusion Drug: Lidocaine infusion Drug: Dexmedetomidine infusion | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 65 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia |
| Actual Study Start Date : | June 1, 2019 |
| Actual Primary Completion Date : | August 1, 2020 |
| Estimated Study Completion Date : | January 12, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV |
Drug: lidocaine and dexmedetomidine infusion
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. Drug: Saline infusion 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 Drug: Lidocaine infusion 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. Drug: Dexmedetomidine infusion 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.
Other Name: Dexmedetomidine |
| Experimental: Effect of infusion saline on PONV |
Drug: lidocaine and dexmedetomidine infusion
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. Drug: Saline infusion 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 Drug: Lidocaine infusion 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. Drug: Dexmedetomidine infusion 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.
Other Name: Dexmedetomidine |
| Experimental: Effect of infusion lidocaine on PONV |
Drug: lidocaine and dexmedetomidine infusion
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. Drug: Saline infusion 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 Drug: Lidocaine infusion 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. Drug: Dexmedetomidine infusion 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.
Other Name: Dexmedetomidine |
| Experimental: Effect of infusion dexmedetomidine on PONV |
Drug: lidocaine and dexmedetomidine infusion
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. Drug: Saline infusion 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 Drug: Lidocaine infusion 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. Drug: Dexmedetomidine infusion 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.
Other Name: Dexmedetomidine |
Primary Outcome Measures :
- postoperative nausea [ Time Frame: 0-2 hours after surgery ]Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
- postoperative nausea [ Time Frame: 2-24 hours after surgery ]Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
- postoperative nausea [ Time Frame: 24-48 hours after surgery ]Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
- postoperative vomiting [ Time Frame: 0-2 hours after surgery ]Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
- postoperative vomiting [ Time Frame: 2-24 hours after surgery ]Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
- postoperative vomiting [ Time Frame: 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) [ Time Frame: 0-2 hours after surgery ]Our primary outcome was the incidence of PONV during the 0-2 hours after surgery
- postoperative nausea and vomiting (PONV) [ Time Frame: 2-24 hours after surgery ]Our primary outcome was the incidence of PONV during the 2-24 hours after surgery
- postoperative nausea and vomiting (PONV) [ Time Frame: 24-48 hours after surgery ]Our primary outcome was the incidence of PONV during the 24-48 hours after surgery
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| Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809923
Contacts
| Contact: Xu Si Qi, Doctor | 13865192106 | errtg555@163.com |
Locations
| China, Anhui | |
| Department of Anqing Hospital Anesthesiology | Recruiting |
| Anqing, Anhui, China, 246000 | |
| Contact: xu siqi errtg555@163.com | |
Sponsors and Collaborators
Anqing Municipal Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anqing Municipal Hospital |
| ClinicalTrials.gov Identifier: | NCT03809923 |
| Other Study ID Numbers: |
xuwen |
| First Posted: | January 18, 2019 Key Record Dates |
| Last Update Posted: | January 13, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Anqing Municipal Hospital:
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Lidocaine Dexmedetomidine Postoperative nausea and vomiting laparoscopic hysterectomy |
Additional relevant MeSH terms:
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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Lidocaine Dexmedetomidine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Analgesics, Non-Narcotic Analgesics Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |