Clinical trial NCT03809923: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
Official title: Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia
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: 2019-01-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
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: 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.


Eligibility criteria: 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

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:
citation: Xu S, Wang S, Hu S, Ju X, Li Q, Li Y. Effects of lidocaine, dexmedetomidine, and their combination infusion on postoperative nausea and vomiting following laparoscopic hysterectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Aug 4;21(1):199. doi: 10.1186/s12871-021-01420-8.