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

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064331
• Other study ID #: FF-2021-024
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: September 2023
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis
• Cholecystolithiasis
• Cholelithiases
• Cholelithiasis
• Gallstones
• Ovarian Cysts

Intervention

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

Locations

Country	Name	City	State
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively	Systolic, diastolic and mean arterial pressure(mmHg) intraoperatively will be recorded and compared between the two groups	Intraoperatively until surgery ends
Secondary	Heart rate (beats per minute) intraoperatively	Heart rate (bpm) intraoperatively will be recorded and compared between the two groups	Intraoperatively until surgery ends
Secondary	Opioid usage (mcg/kg)	Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively	Intraoperatively until surgery ends