ClinicalTrials.gg
CompletedNCT03276533Updated Mar 10, 2022

Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines

An interventional study of Saline and Lidocaine in Anesthesia; Reaction, sponsored by Anqing Municipal Hospital. Completed at 1 site in China. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Anqing Municipal Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Anesthesia; Reaction

Keywords

  • dexmedetomidine; lidocaine; cytokine
03

In context

Lead sponsor

Anqing Municipal Hospital is the lead sponsor of 11 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Intravenous saline, dexmedetomidine and lidocaine

    Drug: Saline · Drug: Lidocaine · Drug: Dexmedetomidine · Drug: Lidocaine plus Dexmedetomidine

  • Experimental
    Intravenous saline, dexmedetomidine, lidocaine and combination

    Drug: Saline · Drug: Lidocaine · Drug: Dexmedetomidine · Drug: Lidocaine plus Dexmedetomidine

  • Experimental
    Intravenous saline,dexmedetomidine plus lidocaine

    Drug: Saline · Drug: Lidocaine · Drug: Dexmedetomidine · Drug: Lidocaine plus Dexmedetomidine

  • Experimental
    Intravenous saline, dexmedetomidine combined with lidocaine

    Drug: Saline · Drug: Lidocaine · Drug: Dexmedetomidine · Drug: Lidocaine plus Dexmedetomidine

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)

  • 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)

  • 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

    Drug pages: Lidocaine · 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)

06

What researchers measure

Primary outcomes

  1. Interleukin-6

    Interleukin-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)

    Time frame: postoperative 24 hours

  2. Tumor necrosis factor-α

    Tumor 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)

    Time frame: postoperative 24 hours

  3. Interleukin-1

    Interleukin-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)

    Time frame: postoperative 24 hours

07

Study locations

1 site
  • Department of Anqing Hospital Anesthesiology
    Anqing, Anhui 246000, China
08

References and documents

Publications

  • 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. PubMed 33407156 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03276533
Lead sponsor
Anqing Municipal Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University
Responsible party
Xu Siqi (Principal Investigator,Department of Anesthesiology, Anqing Municipal Hospital) — Principal investigator
First posted
Sep 8, 2017
Start date
Nov 1, 2017
Primary completion
Aug 6, 2020
Completion
Aug 10, 2020
Last update
Mar 10, 2022

Study contacts

Wang shenbing
study director · Department of Anqing Hospital Anesthesiology
Xiao jingbo
principal investigator · Department of Anqing Hospital Anesthesiology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Lidocaine · Dexmedetomidine

Start the discussion