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

September 28, 2023 updated by: Universiti Kebangsaan Malaysia Medical Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
        • Pusat Perubatan Universiti Kebangsaan Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 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.
Drug: Lignocaine
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 Comparator: Group 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.
Drug: Placebo
IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperatively until surgery ends
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
Intraoperatively until surgery ends
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
Intraoperatively until surgery ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperatively until surgery ends
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
Intraoperatively until surgery ends
Opioid usage (mcg/kg)
Time Frame: Intraoperatively until surgery ends
Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively
Intraoperatively until surgery ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Principal Investigator: Syarifah Noor Nazihah Sayed Masri, MD, National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2021-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

5 years within study period

IPD Sharing Access Criteria

Registered with clinicaltrials.gov

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cysts

Clinical Trials on Lignocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe