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Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines

Primary Purpose

Anesthesia; Reaction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Saline
Lidocaine
Dexmedetomidine
Lidocaine plus Dexmedetomidine
Sponsored by
Anqing Municipal Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia; Reaction focused on measuring dexmedetomidine; lidocaine; cytokine

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anqing Hospital Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Intravenous saline, dexmedetomidine and lidocaine

Intravenous saline, dexmedetomidine, lidocaine and combination

Intravenous saline,dexmedetomidine plus lidocaine

Intravenous saline, dexmedetomidine combined with lidocaine

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
August 23, 2017
Last Updated
March 8, 2022
Sponsor
Anqing Municipal Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03276533
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anqing Municipal Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Reaction
Keywords
dexmedetomidine; lidocaine; cytokine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous saline, dexmedetomidine and lidocaine
Arm Type
Experimental
Arm Title
Intravenous saline, dexmedetomidine, lidocaine and combination
Arm Type
Experimental
Arm Title
Intravenous saline,dexmedetomidine plus lidocaine
Arm Type
Experimental
Arm Title
Intravenous saline, dexmedetomidine combined with lidocaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Lidocaine plus Dexmedetomidine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Interleukin-6
Description
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
Title
Tumor necrosis factor-α
Description
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
Title
Interleukin-1
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang shenbing
Organizational Affiliation
Department of Anqing Hospital Anesthesiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiao jingbo
Organizational Affiliation
Department of Anqing Hospital Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anqing Hospital Anesthesiology
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33407156
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.
Results Reference
derived

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Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines

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