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

N

National University of Malaysia (UKM)

Status

Completed

Conditions

Appendicitis
Ovarian Cysts
Cholelithiases

Treatments

Drug: Placebo
Drug: Lignocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06064331
FF-2021-024

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups, including a placebo group

Group Lignocaine
Experimental group
Description:
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.
Treatment:
Drug: Lignocaine
Group Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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