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

NCT06064331 | Completed DMC

• 1 other identifier: FF-2021-024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiases; Appendicitis; Ovarian Cysts

Keywords

Lignocaine; Desflurane

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  Percentage of reduction of cost of desflurane between the 2 groups

  Intraoperatively until surgery ends

Secondary Outcomes (3)

• Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively

  Intraoperatively until surgery ends

• Heart rate (beats per minute) intraoperatively

  Intraoperatively until surgery ends

• Opioid usage (mcg/kg)

  Intraoperatively until surgery ends

Study Arms (2)

Group Lignocaine

EXPERIMENTAL

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

Group Placebo

PLACEBO COMPARATOR

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

Interventions

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

Group Lignocaine

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

Group Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (11)

• Weinberg L, Jang J, Rachbuch C, Tan C, Hu R, McNicol L. The effects of intravenous lignocaine on depth of anaesthesia and intraoperative haemodynamics during open radical prostatectomy. BMC Res Notes. 2017 Jul 6;10(1):248. doi: 10.1186/s13104-017-2570-4.

  PMID: 28683817 BACKGROUND

• Yang SS, Wang NN, Postonogova T, Yang GJ, McGillion M, Beique F, Schricker T. Intravenous lidocaine to prevent postoperative airway complications in adults: a systematic review and meta-analysis. Br J Anaesth. 2020 Mar;124(3):314-323. doi: 10.1016/j.bja.2019.11.033. Epub 2020 Jan 28.

  PMID: 32000978 BACKGROUND

• Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.

  PMID: 17197840 BACKGROUND

• Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.

  PMID: 16952918 BACKGROUND

• Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.

  PMID: 15041597 BACKGROUND

• Reed R, Doherty T. Minimum alveolar concentration: Key concepts and a review of its pharmacological reduction in dogs. Part 2. Res Vet Sci. 2018 Jun;118:27-33. doi: 10.1016/j.rvsc.2018.01.009. Epub 2018 Feb 2.

  PMID: 29421482 BACKGROUND

• Acevedo-Arcique CM, Ibancovichi JA, Chavez JR, Gutierrez-Blanco E, Moran-Munoz R, Victoria-Mora JM, Tendillo-Cortijo F, Santos-Gonzalez M, Sanchez-Aparicio P. Lidocaine, dexmedetomidine and their combination reduce isoflurane minimum alveolar concentration in dogs. PLoS One. 2014 Sep 18;9(9):e106620. doi: 10.1371/journal.pone.0106620. eCollection 2014.

  PMID: 25232737 BACKGROUND

• Rezende ML, Wagner AE, Mama KR, Ferreira TH, Steffey EP. Effects of intravenous administration of lidocaine on the minimum alveolar concentration of sevoflurane in horses. Am J Vet Res. 2011 Apr;72(4):446-51. doi: 10.2460/ajvr.72.4.446.

  PMID: 21453144 BACKGROUND

• Pypendop BH, Ilkiw JE. The effects of intravenous lidocaine administration on the minimum alveolar concentration of isoflurane in cats. Anesth Analg. 2005 Jan;100(1):97-101. doi: 10.1213/01.ANE.0000139350.88158.38.

  PMID: 15616060 BACKGROUND

• Kapoor MC, Vakamudi M. Desflurane - revisited. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):92-100. doi: 10.4103/0970-9185.92455.

  PMID: 22345954 BACKGROUND

• Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.

  PMID: 9459225 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Appendicitis; Ovarian Cysts

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Syarifah Noor Nazihah Sayed Masri, MD

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: October 3, 2023
• Study Start: January 21, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 5 years within study period
• Access Criteria: Registered with clinicaltrials.gov

Locations

MY (1)