A Phase 4 interventional study of intravenous lidocaine (IVL) and Placebo in Intravenous Lidocaine and Immunity, sponsored by Ciusss de L'Est de l'Île de Montréal. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Phase 4, Interventional, and Treatment
This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.
Hypothesis: We hypothesize that the intravenous lidocaine (IVL) versus placebo administered during laparoscopic colorectal surgery will allow for: a reduction in intraoperative remifentanil consumption, an improvement in patients' early rehabilitation after surgery, and an enhancement of the immune profile of our patients through an increase in the balance Th1/Th2 and cellular immunity.
Background: so far, IVL was shown to have several properties: analgesic, anti-inflammatory, and anti-hyperalgesic. Its effects on rehabilitation and pain are still controversial except for abdominal surgery. To date, no study evaluated the impact of IVL in colorectal surgery on intraoperative consumption of remifentanil. Postoperative immune suppression is multifactorial and depends on the surgical traumatism, but also on the doses of opioids given during anesthesia. No study evaluated in colorectal surgery the impact of IVL on postoperative cellular immunity and on the risk of cancer recurrence.
Specific Objectives: primary objective: to reduce by 30% the consumption of remifentanil in the IVL group versus the placebo group; secondary objectives: to evaluate the quality of recovery from anesthesia in the OR (awakening and extubation time), in the PACU and on the wards (pain scores, opioid consumption with patient controlled analgesia (PCA), postoperative nausea and vomiting (PONV), transit recovery time, time in PACU and time in hospital), and to evaluate the postoperative inflammatory parameters and adaptative immune functions (Th1/Th2) until postoperative 48h.
Methods: 60 adult patients ASA 1-3 scheduled for elective laparoscopic colorectal surgery will be included in this randomized controlled trial. Randomisation will be into group Control (C) and Lidocaine (IVL). Anesthesia and monitoring will be standardized and accompanied with the monitoring of the depth of anesthesia (BISpectral index, Medtronic) and the depth of analgesia (NoL index, Medasense LTD, recorded on an observational manner). IVL group will blindly be administered intravenous 1.5 mg/kg lidocaine bolus and then 1.5 mg/kg/h until the end of the surgery as previously described. C group will receive the same amount (ml) of placebo. Statistics: a preliminary analysis (idem group C) showed that the total amount of remifentanil given for this type of surgery was 2481+/-985 mcg (duration 141+/-30Min). Considering that we wish to reduce by 30% the remifentanil consumption in the group IVL, the number of patients to be included per group is 30 (alpha 0.05 and beta 20%).
Significance/Importance: this study will evaluate the impact of IVL on intraoperative consumption of remifentanil but also on immune functions after surgery in order to reduce the risk of cancer recurrence. If this study brings positive results, this will lead to a significant change in clinical practice of anesthesia. This is a pilot study on the immune functions, but this might bring very strong results to ask for future grants on the impact of IVL on cancer recurrence.
Study Design: Prospective, randomized controlled study. Subject Population: Adult patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia.
Sample Size: 60 patients will be evaluated in this study. Study Duration: 1 year. Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 90 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia.
Drug: intravenous lidocaine (IVL)
Will receive the same volume of normal saline for the entire duration of anesthesia.
Other: Placebo
lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo).
Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg.
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine group compared with the control group.
Time frame: Intra-operative, 5 hours
Evaluation of the number of remifentanil boluses given intraoperatively (n)
Evaluation of the number of remifentanil boluses given intraoperatively, based on the intraoperative NOL index from T0 which is the time of the incision
Time frame: T0 to end of surgery, 5 hours
Assessment of total consumption of inhaled anesthetic desflurane in ml
The Dräger Perseus A500 that we have in each anesthesia room offers the opportunity to get the ml of halogenous gas consumed precisely, and our electronic extraction database will allow to have this data in ml per second and the total at the end of surgery
Time frame: intra-operative
Evaluation of time for extubation
Evaluation of time for extubation after surgery in the operating room
Time frame: post-operative 1 hour
Evaluation of the hydromorphone dose in mg used in the post-operative care unit (PACU) titration
Evaluation of the hydromorphone dose in mg used as post-operative titration immediately in the recovery room (PACU) to obtain NRS pain scores \< 3/10
Time frame: in recovery room, 3 hours
Evaluation of the nausea and vomiting scores, 0 to 3 scale
Evaluation of the nausea and vomiting scores (0 to 3) for the first 48 hours
Time frame: 48 hours
Evaluation of the length of stay in the recovery room based on the Aldrete scores (Score from 0 to 9)
Evaluation of the length of stay in the recovery room based on the Aldrete scores (time to be ready to leave the recovery room)
Time frame: in recovery room, 3 hours
total hydromorphone consumption (mg) after PACU, on wards
total hydromorphone consumption (mg given by Patient Controlled Analgesia) on wards for 48 hours
Time frame: 48 hours
Evaluation of the satisfaction of the patient scale 0 to 100 (%)
Evaluation of the satisfaction of the patient as for the management of his pain for 48 hours
Time frame: 48 hours postoperatively
Assessment of total hospital duration of stay in hours
Assessment of total hospital stay in hours
Time frame: 7 days postoperatively
Evaluation of the time in hours required for the emission of a first gas in hours
Evaluation of the time in hours required for the emission of a first gas, a sign of resumption of normal intestinal function
Time frame: 5 days postoperatively
Assessment of rehabilitation scores and cognitive functions
Assessment of rehabilitation scores and cognitive functions at 48h after surgery
Time frame: 2 days
Assessment of cytokines in plasma
Assessment of inflammation parameters by blood sample for 48 hours
Time frame: 48 hours
Plan to share: No
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Studies of the drug tested here: Lidocaine
Ciusss de L'Est de l'Île de Montréal