Preoperative SedationNCT04760041
Nebulized vs. Oral Midazolam Sedation in Pediatric Anesthesia: A Randomized Comparative Study
A study testing Midazolam nebulized and Midazolam oral solution in people with Preoperative Sedation, run by Cairo University at 1 site in Egypt.
Trial summary
This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Sedation
- What is being tested?
- Midazolam nebulized and Midazolam oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures.
- Duration of surgery 1-2 hours
- Gender eligible for the study: both.
- ASA I-II.
Who cannot join
- ASA III-IV
- Patients with elevated levels of serum ALT, Creatinine.
- Emergency surgeries.
- Pre-existing neurologic disease.
- Parent refusal.
- History of allergy to midazolam.
- Patients with atopy or a history of asthma.
- Lengthy procedures of more than 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study
This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.
Read the detailed description
This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.
In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.
level of sedation will be compared between both groups
- Conditions
- Preoperative Sedation
- Being tested
- Midazolam nebulized, Midazolam oral solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam nebulizedDrug
Also called nebulizer
midazolam nebulized
Midazolam oral solutionDrug
Also called oral
midazolam given oral
| Study group | Role | What they receive |
|---|---|---|
| nebulized midazolam group | Active comparator | 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice 30 min before undergoing general anesthesia Receives: Drug: Midazolam nebulized |
| oral midazolam group | Active comparator | 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing anesthesia Receives: Drug: Midazolam oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to reach a satisfactory level of sedation
time to reach ramsay sedation score 4
Measured: from time of applying the nebulizer until 30 minutes
Secondary outcomes (7)
Acceptability of method of administration of midazolam by a grading system
Facemask acceptance will be graded as poor (terrified, crying, and combative),fair (moderate fear of mask not calmed with reassurance),good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily).
Measured: from time of giving midazolam oral or nebulized till 30 minutes
Ease of separation from parents
using ease of separation and induction scoring system:
- Excellent: patient unafraid, cooperative, or asleep
- Good: slight fear and/or crying, quiet with reassurance
- Fair: moderate fear and crying, not quiet with reassurance
- Poor: crying, need for restraint
Measured: from 30 minutes after receiving midazolam till transfer to operating room
acceptability of Face mask by grading systen
Facemask acceptance was graded as poor (terrified, crying, and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily)
Measured: from time of applying face mask till time of getting asleep at 1 minute intervals
Recovery time
time to recover
Measured: time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals
Changes in mean arterial blood pressure
Changes in mean arterial blood pressure measured in mmHg
Measured: from start of sedation till 1 hour postoperative at 5 minute intervals
changes in oxygen saturation
changes in oxygen saturation
Measured: from start of sedation till 1 hour postoperative at 5 minute intervals
changes in heart rate
changes in heart rate
changes in heart rate (beats per minute)
Measured: from start of sedation till 1 hour postoperative at 5 minute intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021
- Primary completion15 Jul 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative SedationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd El Moneim Soaida, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760041
- Sponsor's protocol ID
- SMS2021-1
- Status last verified
- Apr 2022
- First submitted
- 8 Feb 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04760041
- Acronym / sponsor ID
- SMS2021-1
- Conditions
- Preoperative Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.
Detailed description
This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.
In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.
level of sedation will be compared between both groups
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nebulized midazolam group | Active comparator | Drug: Midazolam nebulized36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice 30 min before undergoing general anesthesia |
| oral midazolam group | Active comparator | Drug: Midazolam oral solution36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing anesthesia |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures.
- Duration of surgery 1-2 hours
- Gender eligible for the study: both.
- ASA I-II.
Key exclusion criteria (8 listed)
- ASA III-IV
- Patients with elevated levels of serum ALT, Creatinine.
- Emergency surgeries.
- Pre-existing neurologic disease.
- Parent refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam nebulizedAlso: nebulizermidazolam nebulized | Drug | nebulized midazolam group |
| Midazolam oral solutionAlso: oralmidazolam given oral | Drug | oral midazolam group |
Primary outcome
Time required to reach a satisfactory level of sedation
Time frame: from time of applying the nebulizer until 30 minutes
time to reach ramsay sedation score 4
7 secondary outcomes
Acceptability of method of administration of midazolam by a grading system
Time frame: from time of giving midazolam oral or nebulized till 30 minutes
Ease of separation from parents
Time frame: from 30 minutes after receiving midazolam till transfer to operating room
acceptability of Face mask by grading systen
Time frame: from time of applying face mask till time of getting asleep at 1 minute intervals
Recovery time
Time frame: time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals
Changes in mean arterial blood pressure
Time frame: from start of sedation till 1 hour postoperative at 5 minute intervals
changes in oxygen saturation
Time frame: from start of sedation till 1 hour postoperative at 5 minute intervals
changes in heart rate
Time frame: from start of sedation till 1 hour postoperative at 5 minute intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Preoperative Sedation
RecruitingObservational study
Consent Understanding and Propofol Requirement During Endobronchial Ultrasound
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Procedural Sedation and Analgesia
Not yet recruitingObservational study
Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort.
Gastric Ultrasound, Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks)
RecruitingObservational study
The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
Anesthesia, Sedation
RecruitingPhase 3
Observation of the Effect of Preoperative Use of Dexmedetomidine Hydrochloride Nasal Spray on Optimizing Awake Sedation During Breast-Conserving Surgery for Breast Cancer and Postoperative Awake Status
Breast Cancer
RecruitingPhase 4
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Preoperative Anxiety, Preoperative Sedation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam nebulized and Midazolam oral solution in people with Preoperative Sedation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to reach a satisfactory level of sedation (time frame: from time of applying the nebulizer until 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.