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Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

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ClinicalTrials.gov Identifier: NCT03809923
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Anqing Municipal Hospital

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.


Condition or disease Intervention/treatment Phase
Lidocaine Dexmedetomidine Nausea and Vomiting, Postoperative Drug: lidocaine and dexmedetomidine infusion Drug: Saline 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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 15, 2020

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

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




Primary Outcome Measures :
  1. postoperative nausea [ Time Frame: 0-2 hours after surgery ]
    Our primary outcome was the incidence of nausea during the 0-2 hours after surgery

  2. postoperative nausea [ Time Frame: 2-24 hours after surgery ]
    Our primary outcome was the incidence of nausea during the 2-24 hours after surgery

  3. postoperative nausea [ Time Frame: 24-48 hours after surgery ]
    Our primary outcome was the incidence of nausea during the 24-48 hours after surgery

  4. postoperative vomiting [ Time Frame: 0-2 hours after surgery ]
    Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery

  5. postoperative vomiting [ Time Frame: 2-24 hours after surgery ]
    Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery

  6. postoperative vomiting [ Time Frame: 24-48 hours after surgery ]
    Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery

  7. 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

  8. 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

  9. 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

Responsible Party: Anqing Municipal Hospital
ClinicalTrials.gov Identifier: NCT03809923     History of Changes
Other Study ID Numbers: xuwen
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anqing Municipal Hospital:
Lidocaine
Dexmedetomidine
Postoperative nausea and vomiting
laparoscopic hysterectomy

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
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