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

Not Applicable

Completed

• Conditions: Cholelithiases; Appendicitis; Ovarian Cysts
• Interventions: Drug: Placebo; Drug: Lignocaine

• Registration Number: NCT06064331
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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.

Study Timeline

• Study Start: 2021-01-21
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Study First Submitted: 2022-06-15
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Placebo	Placebo	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.
Group Lignocaine	Lignocaine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pusat Perubatan Universiti Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia