Cholelithiases, Appendicitis, Ovarian Cysts
Conditions
Keywords
Lignocaine, Desflurane
Brief summary
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
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.
Interventions
DRUGLignocaine
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
DRUGPlacebo
IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anaesthesiology (ASA) I or II patients. 2. Patients aged between 18-75 years of age. 3. Patients scheduled for elective laparoscopic cholecystectomy. 4. Patients scheduled for laparoscopic hernioplasty. 5. Patients scheduled for emergency laparoscopic appendicectomy. 6. Patients scheduled for emergency laparoscopic cystectomy. 7. Patient weight ranging from 50 - 100 kg. 8. Surgery lasting at least one hour.
Exclusion criteria
1. Patients with a known allergy to study drug. 2. Patients with body mass index (BMI) more than 35 kg m-2. 3. Patients who are taking sedatives. 4. Patients with chronic substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End Tidal Desflurane at Bispectral Index (BIS) 40-60 | Intraoperatively until surgery ends | Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group |
| Volume of Desflurane used to maintain BIS 40-60 | Intraoperatively until surgery ends | Percentage of reduction of desflurane volume required during surgery between Lignocaine Group Versus Placebo Group |
| Cost of Desflurane used to maintain BIS 40-60 | Intraoperatively until surgery ends | Percentage of reduction of cost of desflurane between the 2 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate (beats per minute) intraoperatively | Intraoperatively until surgery ends | Heart rate (bpm) intraoperatively will be recorded and compared between the two groups |
| Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively | Intraoperatively until surgery ends | Systolic, diastolic and mean arterial pressure(mmHg) intraoperatively will be recorded and compared between the two groups |
| Opioid usage (mcg/kg) | Intraoperatively until surgery ends | Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively |
Countries
Malaysia
Outcome results
None listed