Procedural SedationPhase 2NCT04873596
Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia
A Phase 2 study testing Nebulized dexmedetomidine and Nebulized midazolam in people with Procedural Sedation, run by Zagazig University at 1 site in Egypt.
Trial summary
Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and… Read more about this study
- Who is it for?
- Ages 21 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Nebulized dexmedetomidine and Nebulized midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2021to 1 Aug 2024
- Phase
- Phase 2
- 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 21 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21-38 years old.
- Mild and moderate preeclampsia parturient.
- American Society of AnesthesiologistPhysical status II.
- Body Mass Index (BMI) (25-35kg/m²).
- Type of operations: elective cesarean section under spinal anesthesia.
- Written informed consent from the parturient.
Who cannot join
- Altered mental state.
- Women with known history of allergy to study drugs.
- Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders.
- Patients receiving anticonvulsants or antidepressants.
- Sever preeclampsia, intrauterine growth restriction or fetal compromise.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University, Faculty of medicine
Zagazig
Alshaimaa Kamel, M.D, 01005593169 ext. 002, AlshaimaaKamel80@yahoo.com
Alshaimaa Kamel, M.D
About this study
Official title: Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal anesthesia in pre-eclamptic parturients
Read the detailed description
Site of study:
This study will be carried out in operating theater of obstetrics at Zagazig University Hospitals.
Withdrawal Criteria: The woman has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
Double -blind randomized clinical trial. All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every woman.
- Conditions
- Procedural Sedation
- Being tested
- Nebulized dexmedetomidine, Nebulized midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized dexmedetomidineDrug
Also called precedex
parturient will receive nebulized 3ug/kg dexmedetomidine.
Nebulized midazolamDrug
Also called Dormicum
parturient will receive nebulized 0.2 mg/kg midazolam.
| Study group | Role | What they receive |
|---|---|---|
| nebulized dexmedetomidine | Active comparator | parturient will receive nebulized 3ug/kg dexmedetomidine diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter. Receives: Drug: Nebulized dexmedetomidine |
| nebulized midazolam | Active comparator | parturient will receive nebulized 0.2 mg/kg midazolam diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter. Receives: Drug: Nebulized midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chane in the level of sedation
Change in the level of sedation will be assessed using Ramasy Sedation Assessment Scale
Ramsay Sedation Scale
1= Patient is anxious and agitated or restless, or both 3= Patient responds to commands only 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6= Patient exhibits no response
Measured: at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative
Secondary outcomes (6)
The discharge time from Post Anesthesia Care Unite (PACU) .
The discharge time from Post Anesthesia Care Unite (PACU) in minutes when achieving modified Aldrete Score 9.
Modified Aldert Score.
Activity, able to move, voluntarily or on command 4 extremities = 2 2 extremities = 1 No = 0
Breathing Able to breathe deeply \& cough freely= 2 Dyspnea, shallow or limited breathing =1 Apnea= 0
Consciousness Fully awake = 2 Arousable on calling = 1 Unresponsive = 0 Circulation (BP) ±20% of pre-anesthesia level= 2
- 20% to 49% of pre-anesthesia level= 1
- 50% of pre-anesthesia level= 0
SPO2 Maintains SpO2 >92% in ambient air= 2 Maintain SpO2 >90% with O2 = 1 Maintain SpO2 <90% with O2 = 0
Measured: up to 30 minutes postoperative
Maternal satisfaction with procedure
Maternal satisfaction with procedure using a 5-point numerical rating scale. 0= Extremely dissatisfied
- Dissatisfied
- Neutral
- Satisfied
- Extremely satisfied
Measured: up to 24hour postoperative
APGAR score
APGAR score at 1 and 5 min after delivery APGAR score (13). Indicator Score 0 Score 1 Score 2 Activity (muscle tone) Limp; no movement Some flexion of arms and legs Active motion Pulse (heart rate) No heart rate Fewer than 100 beats per minute At least 100 beats per minute Grimace (reflex response) No response to airways being suctioned Grimace during suctioning Grimace and pull away, cough, or sneeze during suctioning Appearance (color) The baby's whole body is completely bluish-gray or pale Good color in body with bluish hands or feet Good color all over Respiration (breathing) Not breathing Weak cry; may sound like whimpering, slow or irregular breathing Good, strong cry; normal rate and effort of breathing
Total Score: 3 and below require immediate resuscitation 4 to 7 may require resuscitative measures 7 to 10 is considered normal
Measured: at 1 and 5 min after delivery
Heart rate
heart rate in beat/ minute
Measured: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Mean arterial blood pressure
Mean arterial blood pressure in mmHg
Measured: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Oxygen saturation
Oxygen saturation by pulse oximetry.
Measured: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start15 May 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Principal investigator, Zagazig University, Faculty of human medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873596
- Sponsor's protocol ID
- 6869
- Status last verified
- Feb 2024
- First submitted
- 25 Apr 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
- ClinicalTrials.gov ID
- NCT04873596
- Acronym / sponsor ID
- 6869
- Conditions
- Procedural Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 May 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 5 May 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.
Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal anesthesia in pre-eclamptic parturients
Detailed description
Site of study:
This study will be carried out in operating theater of obstetrics at Zagazig University Hospitals.
Withdrawal Criteria: The woman has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
Double -blind randomized clinical trial. All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every woman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nebulized dexmedetomidine | Active comparator | Drug: Nebulized dexmedetomidineparturient will receive nebulized 3ug/kg dexmedetomidine diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter. |
| nebulized midazolam | Active comparator | Drug: Nebulized midazolamparturient will receive nebulized 0.2 mg/kg midazolam diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 21-38 years old.
- Mild and moderate preeclampsia parturient.
- American Society of AnesthesiologistPhysical status II.
- Body Mass Index (BMI) (25-35kg/m²).
- Type of operations: elective cesarean section under spinal anesthesia.
Key exclusion criteria (5 listed)
- Altered mental state.
- Women with known history of allergy to study drugs.
- Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders.
- Patients receiving anticonvulsants or antidepressants.
- Sever preeclampsia, intrauterine growth restriction or fetal compromise.
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 |
|---|---|---|
| Nebulized dexmedetomidineAlso: precedexparturient will receive nebulized 3ug/kg dexmedetomidine. | Drug | nebulized dexmedetomidine |
| Nebulized midazolamAlso: Dormicumparturient will receive nebulized 0.2 mg/kg midazolam. | Drug | nebulized midazolam |
Primary outcome
Chane in the level of sedation
Time frame: at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative
Change in the level of sedation will be assessed using Ramasy Sedation Assessment Scale Ramsay Sedation Scale 1= Patient is anxious and agitated or restless, or both 3= Patient responds to commands only 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6= Patient exhibits no response
6 secondary outcomes
The discharge time from Post Anesthesia Care Unite (PACU) .
Time frame: up to 30 minutes postoperative
Maternal satisfaction with procedure
Time frame: up to 24hour postoperative
APGAR score
Time frame: at 1 and 5 min after delivery
Heart rate
Time frame: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Mean arterial blood pressure
Time frame: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Oxygen saturation
Time frame: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
Alshaimaa Kamel, M.D principal investigator
Zagazig University, Faculty of human medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nebulized dexmedetomidine and Nebulized midazolam in people with Procedural Sedation, run by Zagazig 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaimaa Kamel, M.D (01005593169 ext. 002, AlshaimaaKamel80@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chane in the level of sedation (time frame: at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative). 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 1 Mar 2024.