Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809923
• Other study ID #: xuwen
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 12, 2021

Study information

• Verified date: March 2022
• 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: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 12, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Anqing Municipal Hospital

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