Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines

Anesthesia; Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276533
• Other study ID #: xuzhang2013
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: August 10, 2020

Study information

• Verified date: March 2022
• Source: Anqing Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 10, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Reaction
• Inflammation

Intervention

Drug:
• Saline
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-a 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)
• Lidocaine
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-a 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)
• Dexmedetomidine
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-a 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)
• Lidocaine 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-a 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)

Locations

Country	Name	City	State
China	Department of Anqing Hospital Anesthesiology	Anqing	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
Anqing Municipal Hospital	The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	postoperative 24 hours
Primary	Tumor necrosis factor-a	Tumor necrosis factor-a level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-a level in serum was measured at the end of the operation (T2); Tumor necrosis factor-a level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-a level in serum was measured at the postoperative 24 hour (T4)	postoperative 24 hours
Primary	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)	postoperative 24 hours