Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

Phase 2Not Yet RecruitingNCT06979791

Cairo University60 enrolled

Overview

The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are: Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. Participants will: Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. Undergo sedation scoring at 15 and 30 minutes after drug administration. Be assessed for ease of separation from parents and acceptance of anesthesia mask. Be monitored for vital signs, recovery times, and any perioperative adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Preoperative Anxiety Experienced by the Pediatric Patient

Eligibility

Sex: ALLMin age: 1 YearMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric patients aged 1 to 8 years * Scheduled for elective surgery under general anesthesia * Surgery duration \< 1 hour * ASA physical status I or II * Parent or legal guardian able to provide informed consent Exclusion Criteria: * Refusal to participate by parent/guardian * Nasal infections, pathology, or epistaxis * Runny nose or upper respiratory tract infection * Enlarged adenoids * BMI \> 30 * Known allergy to dexmedetomidine or midazolam * Fever on day of surgery * Coagulopathy * Scheduled for cardiothoracic or neurosurgical procedures * Congenital heart disease * Neurological or mental disorders * Pre-existing sedation (MOASS \< 5) on the day of surgery

Outcomes

Primary Outcomes

Mask Acceptance Score (MAS) at time of induction

Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.

Time frame: At the time of induction (approximately 30 minutes after premedication)

Secondary Outcomes

Sedation Level (MOASS) at 15 and 30 minutes after premedication

Sedation will be evaluated using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS). Scores will be recorded at 15 and 30 minutes after intranasal drug administration.

Time frame: 15 minutes and 30 minutes after drug administration

Child-Parent Separation Score

Measured using the Child-Parent Separation Scale at the time of separation from parents. Scores of 1 or 2 indicate satisfactory separation; score of 3 indicates poor separation.

Time frame: Approximately 30 minutes after premedication (at time of separation)

Heart Rate

Heart rate will be monitored at baseline and at the time of transfer to the operating room. Mean heart rate values will be compared between the two groups.

Time frame: Baseline and immediately before anesthesia induction.

Blood Pressure

Mean blood pressure will be monitored at baseline and at the time of transfer to the operating room. Mean blood pressure values will be compared between the two groups.

Time frame: Baseline and immediately before anesthesia induction

Time to Recovery (Modified Aldrete Score ≥ 9)

The time from extubation to achieving a Modified Aldrete Score of ≥9 will be recorded.

Time frame: From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU)

Perioperative Adverse Events

Incidence of adverse effects such as nasal irritation, nausea, vomiting, paradoxical reactions, respiratory depression, etc., will be recorded and compared between groups.

Time frame: From the time of drug administration until 1 hour post-discharge from the Post-Anesthesia Care Unit (PACU), or until the occurrence of a recorded adverse event, whichever comes first.