Sevoflurane Versus Propofol for Laryngeal Mask Airway Placement in Children Undergoing Surgery
Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
The goal of this clinical trial is to compare two commonly used anesthetic medicines, sevoflurane and propofol, for inserting a laryngeal mask airway (LMA) in children undergoing minor elective surgery. A laryngeal mask airway is a device placed in the throat to help children breathe safely during anesthesia.
The main questions this study aims to answer are:
- Does sevoflurane produce a faster onset of anesthesia than propofol?
- Is there a difference between sevoflurane and propofol in the time required to achieve jaw relaxation for LMA insertion?
- Is there a difference between the two medicines in the time required for successful LMA insertion?
The researchers hypothesize that children receiving sevoflurane will have a shorter induction time than those receiving propofol.
A total of 170 children aged 4 to 12 years who are undergoing minor surgical procedures below the umbilicus will participate in the study. Participants will be randomly assigned to receive either intravenous propofol or inhaled sevoflurane for induction of anesthesia.
During the procedure, the anesthesia team will measure the time taken to lose consciousness, the time required to achieve adequate jaw relaxation, and the time needed for successful insertion of the laryngeal mask airway. These measurements will help determine which anesthetic agent provides better conditions for LMA insertion in children.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Punjab Province
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Multan, Punjab Province, 파키스탄, 60000
- Children's Hospital and Institute of Child Health Multan
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- ASA physical status 1 and 2
- Undergoing elective minor surgical procedures below umbilicus
- Procedure lasting less than 60 min
Exclusion Criteria:
- Recent respiratory tract infection
- Bronchial asthma
- Family history of malignant hyperthermia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Propofol Group
Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion.
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Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.
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실험적: Sevoflurane Group
hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion.
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Sevoflurane 7% will be delivered via inhalation in a nitrous oxide/oxygen mixture (2:1) for induction of general anesthesia prior to LMA insertion in pediatric patients.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Induction of Anesthesia
기간: From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
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Time (in seconds) measured from administration of the induction agent (propofol or sevoflurane) to loss of consciousness, defined as loss of verbal response and loss of eyelash reflex in pediatric patients undergoing elective surgery for laryngeal mask airway insertion.
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From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Jaw Relaxation
기간: From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
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Time (in seconds) measured from administration of induction agent to adequate jaw relaxation, defined as sufficient mouth opening (>4 cm) allowing insertion of laryngeal mask airway.
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From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
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Time to Laryngeal Mask Airway (LMA) Insertion
기간: From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
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Time (in seconds) measured from administration of induction agent to successful insertion of laryngeal mask airway using standard technique.
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From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
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공동 작업자 및 조사자
수사관
- 연구 의자: Syed S Abbas, FCPS, Children's Hospital and Institute of Child Health, Multan
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- U1111-1342-4662
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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