Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements

Study Overview
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Brief Summary
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Lignocaine is a local anaesthetic that is widely used in all medical and surgical fields. Many clinical studies have shown that intravenous (IV) lignocaine given in the perioperative period was safe, reduced airway complications, obtunds cough reflex, reduce sore throat, pain, opioid consumption, nausea, length of hospital stay. Multiple animal studies have shown that IV lignocaine was able to lower anaesthetic gas requirements. Desflurane is an anaesthetic gas that has a rapid onset and offset of action. This study aims to evaluate the effect of IV lignocaine infusion on desflurane requirements. Hypothesis of the study is that IV lignocaine infusion reduces desflurane requirements.

Detailed Description
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All volunteers will be randomly assigned into two groups based on computer generated randomisation tables. Group Lignocaine will receive an IV bolus dose of 1.5 mg/kg of 2% lignocaine HCL diluted up to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg/kg/h of 2% lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump. Group Placebo will receive an IV bolus of 10 ml of normal saline over a period of 3 min followed by an IV infusion of an equal volume of normal saline, both of which will be delivered by separate syringe pumps. After induction of anaesthesia, all volunteers will be ventilated with Aisys™ CS² anaesthesia machine. Anaesthesia shall be maintained with desflurane, in 50% oxygen-air balance with a total flow of 1.0 L/min. The end tidal desflurane (Et-Des) concentration will be adjusted to maintain a target BIS of between 40-60. Desflurane and study infusions will be discontinued and estimation of desflurane cost and volume used will be estimated at the end of surgery.

Official Title
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Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements: A Randomised Double-Blinded Controlled Study

Conditions
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Cholelithiases, Appendicitis, Ovarian Cysts

Intervention / Treatment
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* Drug: Lignocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiology (ASA) I or II patients. Patients aged between 18-75 years of age. Patients scheduled for elective laparoscopic cholecystectomy. Patients scheduled for laparoscopic hernioplasty. Patients scheduled for emergency laparoscopic appendicectomy. Patients scheduled for emergency laparoscopic cystectomy. Patient weight ranging from 50 - 100 kg. Surgery lasting at least one hour. Exclusion Criteria: Patients with a known allergy to study drug. Patients with body mass index (BMI) more than 35 kg m-2. Patients who are taking sedatives. Patients with chronic substance abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Lignocaine<br>Group Lignocaine will receive an IV bolus dose of 1.5 mg/kg of 2% lignocaine HCL diluted up to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg/kg/h of 2% lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump. | Drug: Lignocaine<br>* IV bolus of 1.5 mg/kg of lignocaine 2% diluted in 10 ml syringe over 3 mins followed by infusion at 1 mg/kg/h of lignocaine 2% in 20 ml syringe<br>|
| Placebo Comparator: Group Placebo<br>Patients in Placebo Group will receive an IV bolus of 10 ml of normal saline over a period of 3 min followed by an IV infusion of an equal volume of normal saline, both of which will be delivered by separate syringe pumps. | Drug: Placebo<br>* IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End Tidal Desflurane at Bispectral Index (BIS) 40-60 | Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group | Intraoperatively until surgery ends | 
| Volume of Desflurane used to maintain BIS 40-60 | Percentage of reduction of desflurane volume required during surgery between Lignocaine Group Versus Placebo Group | Intraoperatively until surgery ends | 
| Cost of Desflurane used to maintain BIS 40-60 | Percentage of reduction of cost of desflurane between the 2 groups | Intraoperatively until surgery ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively | Systolic, diastolic and mean arterial pressure(mmHg) intraoperatively will be recorded and compared between the two groups | Intraoperatively until surgery ends | 
| Heart rate (beats per minute) intraoperatively | Heart rate (bpm) intraoperatively will be recorded and compared between the two groups | Intraoperatively until surgery ends | 
| Opioid usage (mcg/kg) | Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively | Intraoperatively until surgery ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lignocaine, Desflurane