Oral Versus Intravenous Magnesium on Emergence Delirium
2026년 7월 1일 업데이트: Osama Rehab, Tanta University
Effect of Oral Versus Intravenous Magnesium on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Two-Center, Randomized, Double-Blind, Placebo-Controlled Study
This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia.
연구 개요
상태
모병
상세 설명
Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness.
Regarding its use as a preventive measure against emergence delirium in children, only intraoperative IV route was studied and the results of previous reports were inconsistent.
Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.
In this novel study, we will compare the use of magnesium via two different routes, either oral route before surgery or IV route after sevoflurane induction, regarding their preventive value against the occurrence of emergence delirium in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence delirium, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may suggest a prophylactic benefit against emergence delirium. So, we hypothesize that either oral or IV magnesium therapy may decrease the incidence of emergence delirium in this setting.
연구 유형
중재적
등록 (추정된)
360
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Osama M Rehab, MD
- 전화번호: 002 +201095210806
- 이메일: osamarehab@med.tanta.edu.eg
연구 장소
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, 이집트, 31527
- 모병
- Tanta University Hospitals
-
연락하다:
- Osama M Rehab, MD
- 전화번호: 002 +201095210806
- 이메일: osamarehab@med.tanta.edu.eg
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Children aged 4 to 7 years
- American Society of Anesthesiologist (ASA) Status I or II
- Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Exclusion Criteria:
- Parents declined to participate in the trial
- Behavioral changes, neurological or psychiatric problems
- Anticonvulsant or sedative drugs
- Physical or developmental abnormalities
- Allergies to magnesium
- cardiovascular, renal, bone, or gastrointestinal diseases.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Oral magnesium group
cases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery.
|
cases will receive preoperative oral magnesium dose of 150 mg (10 ml of Magnesium Glycinate Liquid Trace syrup) at two hours before surgery, and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
|
|
실험적: Intravenous magnesium group
cases will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
|
cases will receive oral lemon juice (10 ml) at two hours before surgery, and will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
|
|
위약 비교기: Control group
cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
|
cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of emergence delirium
기간: Up to 1 hour after surgery.
|
Pediatric Anesthesia Emergence Delirium scale will be used and a score >12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium.
it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour
|
Up to 1 hour after surgery.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Severity of emergence delirium
기간: Up to 1 hour after surgery.
|
Pediatric Anesthesia Emergence Delirium scale scores will be recorded
|
Up to 1 hour after surgery.
|
|
Postoperative pain
기간: Up to 1 hour after surgery.
|
the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery.
A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl
|
Up to 1 hour after surgery.
|
|
Parental separation anxiety
기간: Perioperative
|
It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale.
It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents.
A score of 1 or 2 was considered as 'acceptable' separation
|
Perioperative
|
|
Mask acceptance
기간: Perioperative
|
The ease of mask acceptance will be graded using the Mask Acceptance Score at the time of induction of general anesthesia with sevoflurane.
It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying).
A score of 1 or 2 was considered 'satisfactory' mask acceptance.
|
Perioperative
|
|
The total dose of rescue propofol
기간: Up to 1 hour after surgery.
|
Parental contact will be initiated as the first line management of delirium.
If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered.
This dose will be repeated after 15 min if the child still agitated.
The total dose of rescue propofol will be recorded.
|
Up to 1 hour after surgery.
|
|
The total dose of rescue fentanyl
기간: Up to 1 hour after surgery.
|
A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl.
This dose will be repeated after 15 min if the child still in pain.
The total dose of rescue fentanyl will be recorded
|
Up to 1 hour after surgery.
|
|
Extubation time
기간: End of surgery.
|
At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned
|
End of surgery.
|
|
Negative behavior changes
기간: 24 hours after surgery.
|
Post Hospitalization Behavior Questionnaire will be used to evaluate the child's baseline behavior before anesthesia and any negative behavioral changes at 24 hours postoperatively.
Significant negative behavioral changes will be defined as ≥ 7 negative changes on the Post Hospitalization Behavior Questionnaire items in comparison with the pre-anesthesia baseline values.
|
24 hours after surgery.
|
|
Side effects
기간: Up to 1 hour after surgery.
|
Postoperative nausea and vomiting , hypotension, bradycardia will be recorded
|
Up to 1 hour after surgery.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 1일
기본 완료 (추정된)
2026년 12월 24일
연구 완료 (추정된)
2026년 12월 25일
연구 등록 날짜
최초 제출
2026년 6월 13일
QC 기준을 충족하는 최초 제출
2026년 6월 13일
처음 게시됨 (실제)
2026년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 1일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 36265PR76/5/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The data will be available upon a reasonable request from the corresponding author.
IPD 공유 기간
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 공유 액세스 기준
The data will be available upon a reasonable request from the corresponding author.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .