Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients
NCT ID: NCT03844984
Last Updated: 2019-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
43 participants
INTERVENTIONAL
2019-02-20
2019-09-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ketamine group
This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
ketamine full dose
This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
Midazolam
This group will receive midazolam 0.05 mg/Kg
Normal saline
This group will receive normal saline 10 mL
Lidocaine-ketamine group
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.
Midazolam
This group will receive midazolam 0.05 mg/Kg
ketamine half dose
This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
Lidocaine
This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.
Interventions
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ketamine full dose
This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
Midazolam
This group will receive midazolam 0.05 mg/Kg
Normal saline
This group will receive normal saline 10 mL
ketamine half dose
This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
Lidocaine
This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With septic shock
* Scheduled for general anesthesia
Exclusion Criteria
* Burn patients
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Hasanin
Assistant professor of anesthesia and critical care
Principal Investigators
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Ashraf Rady, Professor
Role: STUDY_CHAIR
Head of department of anesthesia, Cairo University, Egypt
Locations
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Ahmed Mohamed Hasanin
Cairo, , Egypt
Countries
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References
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Fathy S, Hasanin A, Mostafa M, Ramzy E, Sarhan K, Almenesey T, Safina AG, Hosny O, Hamden GA, Gado AA, Mokhtar A. The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100731. doi: 10.1016/j.accpm.2020.06.017. Epub 2020 Sep 5.
Other Identifiers
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N128-2018
Identifier Type: -
Identifier Source: org_study_id
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