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Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines

Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03276533
Enrollment
160
Registered
2017-09-08
Start date
2017-11-01
Completion date
2020-08-10
Last updated
2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Reaction

Keywords

dexmedetomidine; lidocaine; cytokine

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).

Interventions

DRUGSaline

Participants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)

DRUGLidocaine

Participants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)

DRUGDexmedetomidine

Participants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)

DRUGLidocaine plus Dexmedetomidine

Participants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)

Sponsors

The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
Anqing Municipal Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Interleukin-6postoperative 24 hoursInterleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)
Tumor necrosis factor-αpostoperative 24 hoursTumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)
Interleukin-1postoperative 24 hoursInterleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026