Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV

NCT03788018 | Completed DMC

• 1 other identifier: AnqingMH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine; Dexmedetomidine; Nausea and Vomiting, Postoperative

Keywords

Lidocaine; Dexmedetomidine; Postoperative nausea and vomiting; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (9)

• postoperative nausea

  Our primary outcome was the incidence of nausea during the 0-2 hours after surgery

  0-2 hours after surgery

• postoperative nausea

  Our primary outcome was the incidence of nausea during the 2-24 hours after surgery

  2-24 hours after surgery

• postoperative nausea

  Our primary outcome was the incidence of nausea during the 24-48 hours after surgery

  24-48 hours after surgery

• postoperative vomiting

  Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery

  0-2 hours after surgery

• postoperative vomiting

  Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery

  2-24 hours after surgery

• postoperative vomiting

  Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery

  24-48 hours after surgery

• 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

• 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

• 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

Study Arms (2)

Effect of IV lidocaine and dexmedetomidine on PONV

EXPERIMENTAL

Drug: lidocaine and dexmedetomidine IV; Drug: saline IV

Effect of IV saline on PONV

EXPERIMENTAL

Drug: lidocaine and dexmedetomidine IV; Drug: saline IV

Interventions

lidocaine and dexmedetomidine IV 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.

Effect of IV lidocaine and dexmedetomidine on PONV; Effect of IV saline on PONV

saline IV 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

Effect of IV lidocaine and dexmedetomidine on PONV; Effect of IV saline on PONV

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
• Aged 40-55 years
• Scheduled for elective laparoscopic hysterectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Xu Siqi: lead

Study Sites (1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 27, 2018
• Study Start: January 1, 2018
• Primary Completion: November 15, 2018
• Study Completion: December 1, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)