ignocaine Infusion in Obesity

Phase 3

Recruiting

• Conditions: Bariatrics (Obesity); Anaesthesiology - Anaesthetics; Diet and Nutrition - Obesity; Surgery - Other surgery

• Registration Number: ACTRN12618001658202
• Lead Sponsor: RBWH Anaesthetic Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-08
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients scheduled for elective laparoscopic abdominal surgery

Surgical duration expected to be of at least 90 minutes duration

Patients of a range of BMIs according to the WHO definitions - 10 patients with a BMI of < 35kg/m2, 10 patients with a BMI of 35-40kg/m2 and 10 patients with a BMI > 40kg/m2

Informed consent by patient or legally authorised representative to participate in study and to store specimens for immediate and future analysis.

Exclusion Criteria

Known or suspected allergy to study drug (lignocaine)

Acute or chronic renal disease (eGFR < 60)

Acute or chronic liver disease

Congestive cardiac failure

Cardiac conduction abnormalities

Pregnancy

History of seizure disorder

Known vascular disease of the upper limb (e.g. Raynauds disease), or other contraindication to arterial catheterisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma Lignocaine Levels[No specific primary timepoint - aim is to measure levels over 4 hours and model continuously over this time period. The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes]

Secondary Outcome Measures

Name	Time	Method
Plasma levels of the primary lignocaine active metabolite - monoethylglycinexylididem (MEGX)[The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes];Plasma levels of the secondary lignocaine active metabolite - glycylxylidide (GX[The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes];Plasma levels of alpha-1-glycoprotein[The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes]