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NCT Number: NCT06064331

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

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.

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Key information

Conditions

Cholelithiases Adnexal Diseases Appendicitis Biliary Tract Diseases Cecal Diseases Cholelithiasis Cysts Digestive System Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Gonadal Disorders Infections Intestinal Diseases Intraabdominal Infections Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lignocaine

Drug

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

Placebo

Drug

IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe

Primary outcomes

  1. End Tidal Desflurane at Bispectral Index (BIS) 40-60

    Time frame: Intraoperatively until surgery ends

    Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group

  2. Volume of Desflurane used to maintain BIS 40-60

    Time frame: Intraoperatively until surgery ends

    Percentage of reduction of desflurane volume required during surgery between Lignocaine Group Versus Placebo Group

  3. Cost of Desflurane used to maintain BIS 40-60

    Time frame: Intraoperatively until surgery ends

    Percentage of reduction of cost of desflurane between the 2 groups

Secondary outcomes

  1. Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively

    Time frame: Intraoperatively until surgery ends

    Systolic, diastolic and mean arterial pressure(mmHg) intraoperatively will be recorded and compared between the two groups

  2. Heart rate (beats per minute) intraoperatively

    Time frame: Intraoperatively until surgery ends

    Heart rate (bpm) intraoperatively will be recorded and compared between the two groups

  3. Opioid usage (mcg/kg)

    Time frame: Intraoperatively until surgery ends

    Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2023
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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