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NCT03846284

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

Status unknown NA Last updated 19 February 2019
What this trial tests

NA trial testing Bupivacaine in Emergence Agitation in 93 participants. Status unknown.

Timeline
8 October 2017
Primary endpoint
15 November 2018
1 August 2019

Quick facts

Lead sponsorMansoura University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposeprevention
Enrollment93
Start date8 October 2017
Primary completion15 November 2018
Estimated completion1 August 2019
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Mansoura University

Who can join

Adults 2 to 6, any sex, with Emergence Agitation or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Bupivacaine

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Data sources for this page

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