Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial
This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2.
Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.
연구 개요
상세 설명
This prospective, randomized, double-blind, controlled clinical trial aims to compare intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication is essential in pediatric anesthesia to reduce preoperative anxiety, facilitate parent-child separation, and improve cooperation during anesthesia induction. Oral midazolam is widely used but has limitations such as variable bioavailability and potential adverse behavioral effects. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has emerged as an alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
Eligible pediatric patients will be prospectively enrolled and randomly assigned to receive either intranasal dexmedetomidine or oral midazolam. A double-blind design will be maintained by administering both oral and intranasal preparations in each group. Premedication will be administered prior to anesthesia induction, and perioperative clinical parameters will be recorded.
This study is expected to provide clinically relevant evidence regarding the effectiveness and safety of intranasal dexmedetomidine compared to oral midazolam, potentially contributing to improved premedication strategies in pediatric anesthesia.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Siyament Cangir, M.D.
- 전화번호: +905534411047
- 이메일: siyamentcangir@gmail.com
연구 연락처 백업
- 이름: Fatma K Acil, M.D.
- 전화번호: +905337225225
- 이메일: acilfatma@gmail.com
연구 장소
-
-
Outside of the US
-
Diyarbakır, Outside of the US, 터키 (Türkiye), 21070
- 모병
- Siyament Cangir
-
연락하다:
- Fatma Acil, M.D.
- 전화번호: +905337225225
- 이메일: acilfatma@gmail.com
-
연락하다:
- Siyament Cangir, M.D.
- 전화번호: +905534411047
- 이메일: siyamentcangir@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pediatric patients aged 2-10 years
- ASA physical status I-II
- Scheduled for elective inguinal or urological surgery under general anesthesia
- Both male and female patients
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Known allergy or hypersensitivity to dexmedetomidine or midazolam
- Presence of significant systemic disease or organ dysfunction
- Cardiac arrhythmia or congenital heart disease
- Neurological or behavioral disorders, including developmental delay
- Chronic use of analgesics or other medications that may affect study outcomes
- Anticipated difficult airway
- Nasal pathology that may interfere with intranasal drug administration
- Emergency surgery
- Inability to obtain written informed consent from parents or legal guardians
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Midazolam Group
Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding.
This approach ensures consistent administration routes across study groups.
|
Oral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
다른 이름들:
|
|
실험적: Dexmedetomidine Group
Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.
|
Intranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients achieving adequate sedation at anesthesia induction
기간: Approximately 30 minutes after premedication, at anesthesia induction
|
Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction
|
Approximately 30 minutes after premedication, at anesthesia induction
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parent-child separation anxiety score
기간: At parent-child separation before anesthesia induction
|
Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of >2 is defined as significant separation anxiety. Unit of Measure: Units on a scale |
At parent-child separation before anesthesia induction
|
|
Mask acceptance at induction
기간: At the time of mask application during anesthesia induction
|
Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction.
Mask Acceptance will be defined as WDS 1-2.
|
At the time of mask application during anesthesia induction
|
|
Postoperative emergence agitation
기간: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
Emergence agitation will be assessed using the Watcha Behavior Scale (WDS).
Agitation will be defined as WDS >2.
|
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
|
Need for rescue sedation
기간: From premedication until anesthesia induction
|
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
|
From premedication until anesthesia induction
|
|
PACU recovery time
기간: During PACU stay until discharge criteria are met
|
Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.
|
During PACU stay until discharge criteria are met
|
|
Postoperative pain score
기간: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
Postoperative pain will be assessed using the FLACC scale.
|
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
|
Extubation time
기간: Intraoperative to immediate postoperative period
|
Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
|
Intraoperative to immediate postoperative period
|
|
Mean Arterial Pressure (MAP)
기간: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period. Unit of Measure: mmHg |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
|
Heart Rate (HR)
기간: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia. Unit of Measure: Beats per minute (bpm) |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
|
Oxygen Saturation (SpO2)
기간: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status. Unit of Measure: Percentage (%) |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 27/01/2026-35
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Midazolam에 대한 임상 시험
-
Al Jedaani Hospital완전한
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.모병
-
University Hospital, Grenoble모병