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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Heart rate (beats per minute) intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syarifah Noor Nazihah Sayed Masri, MD | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusat Perubatan Universiti Kebangsaan Malaysia | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683817 | Background | 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. | |
| 32000978 | 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. |
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5 years within study period
Registered with clinicaltrials.gov
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 25, 2021 | Sep 27, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001064 | Appendicitis |
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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 |
|
Heart rate (bpm) intraoperatively will be recorded and compared between the two groups |
| Intraoperatively until surgery ends |
| Opioid usage (mcg/kg) | Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively | Intraoperatively until surgery ends |
| 17197840 | 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. |
| 16952918 | 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. |
| 15041597 | 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. |
| 29421482 | 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. |
| 25232737 | 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. |
| 21453144 | 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. |
| 15616060 | 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. |
| 22345954 | Background | Kapoor MC, Vakamudi M. Desflurane - revisited. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):92-100. doi: 10.4103/0970-9185.92455. |
| 9459225 | 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. |
| D005759 |
| Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Aniline Compounds |
| D000588 | Amines |