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

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.

Conditions

• Emergence Agitation
• Postoperative Pain

Interventions

DRUG

Bupivacaine

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

DRUG

Magnesium sulfate 50mg

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

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.

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Principal Investigators

• Gehan Ad Tarabeah, MD · Profosser of anesthesia and surgical intensive care

• Hesham Ah Abdel Mohaiemn, MD · Assisstant professor of anesthesia and surgical intensive care

• Marwa Ib Abdo, MD · Lecturer of anesthesia and surgical intensive care

• Mahmoud Mo Abdel latef, Ph.D · Resident of anesthesia and surgical intensive care

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

2 Years

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-08

Primary Completion

2018-11-15

Completion

2019-08-01

Countries

• Egypt

Study Locations