Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV

Dexmedetomidine Clinical Trial

Official title:

Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788018
• Other study ID #: AnqingMH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: Anqing Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status?and ?

• Aged 40-55 years

• Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

• History of allergy to local anesthetics

• 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

Related Conditions & MeSH terms

• Dexmedetomidine
• Lidocaine
• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• lidocaine and dexmedetomidine IV
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 IV
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

Locations

Country	Name	City	State
China	Department of Anqing Hospital Anesthesiology	Anqing	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Xu Siqi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative nausea	Our primary outcome was the incidence of nausea during the 0-2 hours after surgery	0-2 hours after surgery
Primary	postoperative nausea	Our primary outcome was the incidence of nausea during the 2-24 hours after surgery	2-24 hours after surgery
Primary	postoperative nausea	Our primary outcome was the incidence of nausea during the 24-48 hours after surgery	24-48 hours after surgery
Primary	postoperative vomiting	Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery	0-2 hours after surgery
Primary	postoperative vomiting	Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery	2-24 hours after surgery
Primary	postoperative vomiting	Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery	24-48 hours after surgery
Primary	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
Primary	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
Primary	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