Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
| Registry | NCT03640468 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 36 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Septic Shock, Anesthesia |
| Interventions | Ketamine full dose, Ketamine half dose, Lidocaine, Midazolam, Normal saline (Drug) |
| Dates | start 2018-12-20 (estimated), primary completion 2019-06-15 (estimated), completion 2019-07-01 (estimated), first posted 2018-08-21, last updated 2018-11-21 |
| Locations | 1 site in Egypt |
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The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.
Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.
Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.
Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ketamine group | Active comparator | Drug: Ketamine full dose; Drug: Midazolam; Drug: Normal saline | This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL. |
| Lidocaine-ketamine group | Experimental | Drug: Ketamine half dose; Drug: Lidocaine; Drug: Midazolam | This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Adult patients aged above 18 years * With septic shock * Scheduled for general anesthesia Exclusion Criteria: * Patients under 18 years * Burn patients
| Facility | City | Country | Status |
|---|---|---|---|
| Cairo University | Cairo | Egypt |