Clinical trial NCT03788018: Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV
Official title: Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lidocaine
Dexmedetomidine
Nausea and Vomiting, Postoperative
Keywords: Lidocaine
Dexmedetomidine
Postoperative nausea and vomiting
laparoscopic hysterectomy
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
* 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

Primary outcomes:
measure: postoperative nausea
timeFrame: 0-2 hours after surgery
measure: postoperative nausea
timeFrame: 2-24 hours after surgery
measure: postoperative nausea
timeFrame: 24-48 hours after surgery
measure: postoperative vomiting
timeFrame: 0-2 hours after surgery
measure: postoperative vomiting
timeFrame: 2-24 hours after surgery
measure: postoperative vomiting
timeFrame: 24-48 hours after surgery
measure: postoperative nausea and vomiting (PONV)
timeFrame: 0-2 hours after surgery
measure: postoperative nausea and vomiting (PONV)
timeFrame: 2-24 hours after surgery
measure: postoperative nausea and vomiting (PONV)
timeFrame: 24-48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
References: