Clinical trial NCT03276533: Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines
Official title: Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Reaction
Keywords: dexmedetomidine; lidocaine; cytokine
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
First posted: 2017-09-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic hysterectomy.

Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA) physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic hysterectomy with general anesthesia from October 2017 to August 2018. The participants were randomly assigned into four groups(n=40 each group): group CON received normal saline infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion), group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4).


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* weighted 50 kg-65 kg
* aged 40-65 yr
* elective laparoscopic hysterectomy with general anesthesia

Exclusion Criteria:

* a history of allergy to local anesthetics
* severe respiratory, renal or hepatic disease
* preoperative opioids medication
* psychiatric medical history
* Patients with severe hypotension \[mean arterial pressure (MAP\<60 mmHg)\] or bradycardia \[heart rate (HR) \<40 beats per minute (bpm)\], arrhythmia, or urticaria due to lidocaine and dexmedetomidine infusion during the surgery

Primary outcomes:
measure: Interleukin-6
timeFrame: postoperative 24 hours
measure: Tumor necrosis factor-α
timeFrame: postoperative 24 hours
measure: Interleukin-1
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
affiliation: Department of Anqing Hospital Anesthesiology
name: Wang shenbing
role: STUDY_DIRECTOR
affiliation: Department of Anqing Hospital Anesthesiology
name: Xiao jingbo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.