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Caudal Versus Intravenous Magnesium Sulfate on Emergence Agitation After Sevoflurane In Children.

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ClinicalTrials.gov Identifier: NCT03846284
Recruitment Status : Unknown
Verified February 2019 by Marwa Ibrahim Abdo, Mansoura University.
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Marwa Ibrahim Abdo, Mansoura University

Brief Summary:

Sevoflurane is the agent of choice for induction and maintenance of day care anesthesia in children and has a wide acceptance among pediatric anesthesiologists.

Emergence agitation (EA) is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery, e.g. sevoflurane Magnesium sulfate is a non anesthetic N-methyl-D-aspartate receptor antagonist, Regional anesthetic techniques have major two benefits which are lowering anesthetic requirements intraoperatively and providing adequate postoperative pain relief.

Magnesium sulfate is an adjuvant that alters the perception and duration of pain by serving as an antagonist of N-methyl-D-aspartate glutamate receptors. Caudal injection of bupivacaine with magnesium sulfate in pediatric patients after inguinoscrotal operations provided adequate postoperative analgesia without producing many side effects. Caudal block with local anesthetic with or without adjuvants may prevent emergence agitation with effective postoperative pain management.

  • So the aim of this study is to compare the efficacy of caudal versus intravenous magnesium sulfate infusions in controlling emergence agitations after inhalational sevoflurane anesthesia in children who will undergo lower abdominal surgeries.

Participants and methods

All participants will receive caudal block with bupivacaine 0.25% 1mg/kg dialed in 10 cm saline.

The participants will be divided to 3 groups

  1. Bupivacaine group (B group) (group 1) N = 31 :-
  2. Magnesium sulfate caudal group (MC group) (group 2) N = 31 :-
  3. Magnesium sulfate I.V group (MV group) (group 3) N = 31 :-

Postoperative assessment in the ( PACU):-

  • The oxygen saturation (SO2), heart rate (HR), and mean arterial pressure (MAP) are monitored by the observer blinded to group allocation on admission and 10 mins till discharge (0, 10, 20, 30, 40, 50, 60mints, time of discharge) from the PACU.
  • Emergence agitations (Pediatric anesthesia emergency delirium scale (PAED) The presence of Emergence agitation and its severity will be measured using (PAED).

The presence of Pain and its severity will be measured using FLACC scale.

  • Time of first postoperative administration of fentanyl in mints
  • Modified Aldrete score :- The discharge from the PACU will be measured using Modified Aldrete score.

Condition or disease Intervention/treatment Phase
Emergence Agitation Postoperative Pain Drug: Bupivacaine Drug: Magnesium sulfate 50mg Drug: Magnesium sulfate 30 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: , prospective, blind,controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The group allocation is concealed in sealed, opaque envelopes, which are not opened until participant consent has been obtained. The participants, their anesthetists, and staff providing postoperative care are blinded to group assignment. The drugs are prepared in equal aliquots with code numbers. Closed envelop will be used
Primary Purpose: Prevention
Official Title: Caudal Versus Intravenous Magnesium Sulfate In The Prevention OF Emergence Agitation After Sevoflurane Anesthesia For Lower Abdominal Surgeries In Children.
Actual Study Start Date : October 8, 2017
Actual Primary Completion Date : November 15, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Bupivacaine (B group)

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.

+ I.V injection of 10 cm saline over 10 mins then, I.V infusion 50 cm saline with rate 10-20 ml/h according to child weight.

Drug: Bupivacaine
caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
Other Name: local anesthetic drug

Experimental: Magnesium sulfate caudal (MC group)

caudal block with bupivacaine 0.25% 1mg/kg + Magnesium sulfate 50 mg diluted in 10 cm saline.

+ I.V injection of 10 cm saline over 10 mins then, I.V infusion of 50 cm saline with rate 10-20 ml/h according to child weight.

Drug: Bupivacaine
caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
Other Name: local anesthetic drug

Drug: Magnesium sulfate 50mg
caudal block with bupivacaine 0.25% 1mg/kg plus Magnesium sulfate 50 mg diluted in 10 cm saline.
Other Name: non anesthetic N-methyl-D-aspartate receptor antagonist

Experimental: Magnesium sulfate I.V (M V group)

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.

+ I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h.

Drug: Bupivacaine
caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
Other Name: local anesthetic drug

Drug: Magnesium sulfate 30 mg

caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.

+ I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, fol I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h.

Other Name: non anesthetic N-methyl-D-aspartate receptor antagonist




Primary Outcome Measures :
  1. Number of Participants With sevoflurane-agitation are Assessed by Pediatric anesthesia emergency delirium scale (PAED) in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone [ Time Frame: up to 96 weeks ]

    (PAED).

    1. The child makes eye contact with care giver
    2. The child's actions are purposeful
    3. The child is aware of his/her surroundings
    4. The child is restless
    5. The child is inconsolable

      • Items 1, 2 and 3 are scored: 4 = not at all, 3 = just a little, 2 quite a bit, 1 = very much, 0 = extremely.
      • Items 4 and 5 are scored: 0 = not at all, 1 = just a little, 2 = quite a bit, 3 = very much, 4 = extremely.
      • minimal score 0 maximal score 20
      • It will be monitored on admission and every 10 mins till discharge from the PACU (0, 10, 20, 30, 40, 50, 60 mins, time of discharge).

    PAED score ≥ 10 fentanyl 1micg/kg I V will be given, repeated after 10 min if still agitated, with a maximum total dose of 2 micg/kg. (PAED) score ≥ 10 will be considered to be a diagnostic endpoint for agitation.



Secondary Outcome Measures :
  1. Number of Participants With Pain and its severity will be measured using FLACC in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone after inhalational sevoflurane anesthesia in children [ Time Frame: up to 96 weeks ]

    FLACC scale

    0 1 2 Face No expression Occasional grimace , . Frequent quivering chin, clenched jaw.

    Legs Normal position . Uneasy,. legs drawn up. Activity Lying quietly. shifting back . Arched, rigid . Cry No cry whimpers; Crying steadily, screams, Consolability Content, . Reassured by being talked to, . Difficulty to console

    • It will be monitored on admission and every 10 mins till discharge from the (0, 10post anesthetic care unit, 20, 30, 40, 50, 60 mins, time of discharge).
    • minimal score is 0.maximal score is 12
    • If the FLACC pain scale score is noted at any time to be 4 or more, 1micg/kg fentanyl I.V and repeated after 10 mins, will be given

    -Time of first postoperative administration of fentanyl in mints -


  2. The discharge from the post anesthetic care unit will be measured using Modified Aldrete score after inhalational sevoflurane anesthesia in children in 3 groups [ Time Frame: up to 96 weeks ]

    Modified Aldrete score

    Activity:

    2. able to move 4 extremities

    1. able to move 2 extremities 0. unable to move extremities

    Respiration:

    2. able to breath deeply

    1. dyspnea 0. apneic

    Circulation:

    2. BP +/- 20% of pre-anesthetic level

    1. BP +/- 49% 0. BP +/- 50%

    Consciousness:

    2. fully awake

    1. arousable on calling 0. not responding

    O2 saturation :

    2. O2 saturation <92% on room air

    1. needs O2 O2 saturation <90% 0. O2 saturation >90%

    • It will be monitored on admission and every 10 mins till discharge from the PACU (0, 10, 20, 30, 40, 50, 60 mins, time of discharge).
    • minimal score is 0 maximal score is 10
    • Patients will be discharged from post anesthetic care unit after adequate control of agitation and pain, and when they has achieved Modified Aldrete score characteristics of ≥ 9,



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-All participants undergoing lower abdominal surgeries

Exclusion Criteria:

All participants with:-

  • history of developmental delay,
  • mental retardation,
  • psychological disorders or
  • Epilepsy which can make observational pain intensity assessment difficult,
  • a known or suspect coagulopathy,
  • a known allergy to any of the study drugs and
  • any signs of infection at the site of the proposed caudal block.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846284


Locations
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Egypt
Marwa ibrahim mohamed abdo
Mansourah, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Gehan Ad Tarabeah, MD Profosser of anesthesia and surgical intensive care
Study Director: Hesham Ah Abdel Mohaiemn, MD Assisstant professor of anesthesia and surgical intensive care
Study Director: Marwa Ib Abdo, MD Lecturer of anesthesia and surgical intensive care
Principal Investigator: Mahmoud Mo Abdel latef, Ph.D Resident of anesthesia and surgical intensive care
Publications:

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Responsible Party: Marwa Ibrahim Abdo, Lecturer of anesthesia and surgical intensive care- principal investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03846284    
Other Study ID Numbers: MS/17.05.159
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marwa Ibrahim Abdo, Mansoura University:
Sevoflurane-
Emergence agitation
Magnesium sulfate
Children
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Dyskinesias
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Delirium
Confusion
Neurocognitive Disorders
Mental Disorders
Magnesium Sulfate
Bupivacaine
Anesthetics, Local
Anesthetics
N-Methylaspartate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents