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

Primary Purpose

Cholelithiases, Appendicitis, Ovarian Cysts

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Lignocaine
Placebo
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiases focused on measuring Lignocaine, Desflurane

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pusat Perubatan Universiti Kebangsaan Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group Lignocaine

Group Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

End Tidal Desflurane at Bispectral Index (BIS) 40-60
Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group
Volume of Desflurane used to maintain BIS 40-60
Percentage of reduction of desflurane volume required during surgery between Lignocaine Group Versus Placebo Group
Cost of Desflurane used to maintain BIS 40-60
Percentage of reduction of cost of desflurane between the 2 groups

Secondary Outcome Measures

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
Heart rate (beats per minute) intraoperatively
Heart rate (bpm) intraoperatively will be recorded and compared between the two groups
Opioid usage (mcg/kg)
Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively

Full Information

First Posted
June 15, 2022
Last Updated
September 28, 2023
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT06064331
Brief Title
Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements
Official Title
Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements: A Randomised Double-Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiases, Appendicitis, Ovarian Cysts
Keywords
Lignocaine, Desflurane

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Lignocaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lignocaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe
Primary Outcome Measure Information:
Title
End Tidal Desflurane at Bispectral Index (BIS) 40-60
Description
Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group
Time Frame
Intraoperatively until surgery ends
Title
Volume of Desflurane used to maintain BIS 40-60
Description
Percentage of reduction of desflurane volume required during surgery between Lignocaine Group Versus Placebo Group
Time Frame
Intraoperatively until surgery ends
Title
Cost of Desflurane used to maintain BIS 40-60
Description
Percentage of reduction of cost of desflurane between the 2 groups
Time Frame
Intraoperatively until surgery ends
Secondary Outcome Measure Information:
Title
Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively
Description
Systolic, diastolic and mean arterial pressure(mmHg) intraoperatively will be recorded and compared between the two groups
Time Frame
Intraoperatively until surgery ends
Title
Heart rate (beats per minute) intraoperatively
Description
Heart rate (bpm) intraoperatively will be recorded and compared between the two groups
Time Frame
Intraoperatively until surgery ends
Title
Opioid usage (mcg/kg)
Description
Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively
Time Frame
Intraoperatively until surgery ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syarifah Noor Nazihah Sayed Masri, MD
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusat Perubatan Universiti Kebangsaan Malaysia
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
5 years within study period
IPD Sharing Access Criteria
Registered with clinicaltrials.gov
Citations:
PubMed Identifier
28683817
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.
Results Reference
background
PubMed Identifier
32000978
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.
Results Reference
background
PubMed Identifier
17197840
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.
Results Reference
background
PubMed Identifier
16952918
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.
Results Reference
background
PubMed Identifier
15041597
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.
Results Reference
background
PubMed Identifier
29421482
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.
Results Reference
background
PubMed Identifier
25232737
Citation
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.
Results Reference
background
PubMed Identifier
21453144
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.
Results Reference
background
PubMed Identifier
15616060
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.
Results Reference
background
PubMed Identifier
22345954
Citation
Kapoor MC, Vakamudi M. Desflurane - revisited. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):92-100. doi: 10.4103/0970-9185.92455.
Results Reference
background
PubMed Identifier
9459225
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.
Results Reference
background

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

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