CholelithiasesNCT06064331
Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements
A study testing Lignocaine in people with Cholelithiases and Appendicitis, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholelithiases, Appendicitis, Ovarian Cysts
- What is being tested?
- Lignocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Jan 2021to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cholelithiases, Appendicitis, Ovarian Cysts
- Being tested
- Lignocaine, Placebo
- Keywords
- Lignocaine, Desflurane
- Medical subject headings
- Cholelithiasis, Appendicitis, Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
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
PlaceboDrug
IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Tidal Desflurane at Bispectral Index (BIS) 40-60
Percentage of reduction in end tidal desflurane between Lignocaine Group Versus Placebo Group
Measured: 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
Measured: Intraoperatively until surgery ends
Cost of Desflurane used to maintain BIS 40-60
Percentage of reduction of cost of desflurane between the 2 groups
Measured: Intraoperatively until surgery ends
Secondary outcomes (3)
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
Measured: Intraoperatively until surgery ends
Heart rate (beats per minute) intraoperatively
Heart rate (bpm) intraoperatively will be recorded and compared between the two groups
Measured: Intraoperatively until surgery ends
Opioid usage (mcg/kg)
Incidence of patients require rescue opioid (mcg/kg) intraoperatively and postoperatively
Measured: Intraoperatively until surgery ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start21 Jan 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CholelithiasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syarifah Noor Nazihah Sayed Masri, MD, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064331
- Sponsor's protocol ID
- FF-2021-024
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28683817Yang 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.
PubMed 32000978Kaba 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.
PubMed 17197840Kuo 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.
PubMed 16952918Koppert 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.
PubMed 15041597Reed 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.
PubMed 29421482Acevedo-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.
PubMed 25232737Rezende 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.
PubMed 21453144Pypendop 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.
PubMed 15616060Kapoor MC, Vakamudi M. Desflurane - revisited. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):92-100. doi: 10.4103/0970-9185.92455.
PubMed 22345954Groudine 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.
PubMed 9459225
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements: A Randomised Double-Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT06064331
- Acronym / sponsor ID
- FF-2021-024
- Conditions
- Cholelithiases, Appendicitis, Ovarian Cysts
- Keywords
- Lignocaine, Desflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Lignocaine | Experimental | Drug: LignocaineGroup 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 | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LignocaineIV 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 | Drug | Group Lignocaine |
| PlaceboIV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe | Drug | Group Placebo |
Primary outcome
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
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
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
3 secondary outcomes
Systolic, diastolic and mean arterial pressure (mmHg) intraoperatively
Time frame: Intraoperatively until surgery ends
Heart rate (beats per minute) intraoperatively
Time frame: Intraoperatively until surgery ends
Opioid usage (mcg/kg)
Time frame: Intraoperatively until surgery ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 28683817Weinberg 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.
- Background: PubMed 32000978Yang 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.
- Background: PubMed 17197840Kaba 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.
- Background: PubMed 16952918Kuo 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.
- Background: PubMed 15041597Koppert 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.
- Background: PubMed 29421482Reed 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.
- Background: PubMed 25232737Acevedo-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.
- Background: PubMed 21453144Rezende 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.
- Background: PubMed 15616060Pypendop 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.
- Background: PubMed 22345954Kapoor MC, Vakamudi M. Desflurane - revisited. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):92-100. doi: 10.4103/0970-9185.92455.
- Background: PubMed 9459225Groudine 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syarifah Noor Nazihah Sayed Masri, MD principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine in people with Cholelithiases and Appendicitis, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End Tidal Desflurane at Bispectral Index (BIS) 40-60 (time frame: Intraoperatively until surgery ends). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064331, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.