Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Not Applicable

Completed

• Conditions: Nausea and Vomiting, Postoperative; Lidocaine; Dexmedetomidine
• Interventions: Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion

• Registration Number: NCT03809923
• Lead Sponsor: 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: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Study Start: 2019-06-01
• Primary Completion: 2020-08-01
• Study Completion: 2021-01-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV	lidocaine and dexmedetomidine infusion	-
Effect of infusion saline on PONV	lidocaine and dexmedetomidine infusion	-
Effect of infusion lidocaine on PONV	lidocaine and dexmedetomidine infusion	-
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV	Lidocaine infusion	-
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV	Dexmedetomidine infusion	-
Effect of infusion dexmedetomidine on PONV	Lidocaine infusion	-
Effect of infusion lidocaine on PONV	Saline infusion	-
Effect of infusion saline on PONV	Saline infusion	-
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV	Saline infusion	-
Effect of infusion lidocaine on PONV	Dexmedetomidine infusion	-
Effect of infusion dexmedetomidine on PONV	Dexmedetomidine infusion	-
Effect of infusion saline on PONV	Lidocaine infusion	-
Effect of infusion saline on PONV	Dexmedetomidine infusion	-
Effect of infusion lidocaine on PONV	Lidocaine infusion	-
Effect of infusion dexmedetomidine on PONV	Saline infusion	-
Effect of infusion dexmedetomidine on PONV	lidocaine and dexmedetomidine infusion	-

Primary Outcome Measures

Name	Time	Method
postoperative nausea	24-48 hours after surgery	Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting	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)	24-48 hours after surgery	Our primary outcome was the incidence of PONV during the 24-48 hours after surgery

Trial Locations

Locations (1)

Department of Anqing Hospital Anesthesiology; 🇨🇳 Anqing, Anhui, China