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NCT Number: NCT03809923

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

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.

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Key information

Conditions

Lidocaine Dexmedetomidine Nausea Nausea and Vomiting, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine and dexmedetomidine infusion

Drug

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.

Saline infusion

Drug

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

Lidocaine infusion

Drug

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.

Dexmedetomidine infusion

Drug

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 names: Dexmedetomidine

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Anqing Municipal Hospital

Other

Registry information

Official study title

Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 18, 2019
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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