Valvular Cardiac SurgeriesNCT06464263
Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation
A study testing Dexmedetomidine in people with Valvular Cardiac Surgeries, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Valvular Cardiac Surgeries
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 10 Feb 2026
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- This study will include patients undergoing elective adult valvular cardiac surgeries
Who cannot join
- Patient refusal.
- Emergent valve cardiac surgeries.
- Patients with known hypersensitivity to study drugs.
- History of uncontrolled diabetes or hypertension.
- Impaired kidney or liver functions.
- Perioperative hemodynamic instability.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University hospitals
Cairo
Ahmed Ramadan Ibrahim, M.D, +201002749797, 782014arar@gmail.com
Assist.Prof.
About this study
Official title: Comparative Study Between Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation After Adult Valvular Cardiac Surgeries; a Prospective Randomized Blinded Clinical Trial
Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy.
Despite the advances in anesthesia and surgical techniques, the duration of mechanical ventilation (MV) may be prolonged after cardiac surgery, due to the classic high-dose narcotic-based cardiac anesthesia.
Read the detailed description
In recent years, fast-track extubation (FTE) protocols have been developed to reduce the long period of intubation and complications that may occur due to the long duration of MV. Potential advantages of FTE protocols following surgery for congenital cardiac disease are reduced ventilator-associated pulmonary complications and the negative effects of positive pressure ventilation, reduced nosocomial infections, postoperative atelectasis, reduced requirements of sedatives and analgesic drugs, early enteral feeding, rapid patient mobilization, and shorter intensive care unit (ICU) stay.
The ideal analgesic-sedative agents would keep the patient comfortable without anxiety. It would effectively provide adequate sedation, but also allow neurologic evaluation of the patient, ideally without stopping administration of the drug. It would have minimal hemodynamic and respiratory depressant effects. It also would have a rapid onset and offset of action without drug accumulation or active metabolites, making it easily titratable and allowing rapid recovery with a prompt return to normal activity after discontinuation.
Opioids and benzodiazepines are the most frequently used analgesic-sedative agents after cardiac surgery. Although opioid can provide excellent analgesia, the doses for effective pain relief may lead to undesirable side effects, such as respiratory depression requiring prolonged MV, hemodynamic instability, tolerance, and significant withdrawal symptoms that also delay patient recovery.
Dexmedetomidine is a highly selective α2-adrenoreceptor agonist. Presynaptic activation of α2-adrenoreceptors at sympathetic nerve endings inhibits catecholamine release. The major effect of dexmedetomidine is maintaining sedation-analgesia without a respiratory depressant effect. It has relatively few cardiovascular side effects and produces sleep-like sedation without narcosis or respiratory depression.
Indeed, current guidelines recommend lighter levels of sedation to manage ventilated patients preferably using nonbenzodiazepine sedatives. Nevertheless, there is currently no consistent recommendation regarding which nonbenzodiazepine sedative agents should be used.
- Conditions
- Valvular Cardiac Surgeries
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called fentanyl 50 mcg/ml
to investigate the postoperative analgesic-sedative effect of dexmedetomidine versus fentanyl-midazolam to achieve fast-track extubation after adult valvular cardiac surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | This Group about 30 patients will receive a loading dose of 1 μg/kg dexmedetomidine (Precedex 4 mcg/ml, Pfizer. Inc, New York, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2-0.7 μg/kg/h. Receives: Drug: Dexmedetomidine |
| Fentanyl Group | Experimental | This Group about 30 patients will receive an initial bolus dose of fentanyl (fentanyl 50 mcg/ml, hameln; Netherlands) of 1-2 μg/kg, followed by an infusion at an initial rate of 1 to 2 μg/kg/h. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relieve
Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Measured: 2 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start10 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Cardiac SurgeriesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed Ibrahim Mohammed Hashish, Professor, Study chair, Al-Azhar University, Faculty of medicineMohamed husseiny Mahmoud, Lecturer, Principal investigator, Cardio-Thoracic Surgery Department, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464263
- Sponsor's protocol ID
- Anesth-._098/2023
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation After Adult Valvular Cardiac Surgeries; a Prospective Randomized Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06464263
- Acronym / sponsor ID
- Anesth-._098/2023
- Conditions
- Valvular Cardiac Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 18 Jun 2024 (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.
Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy.
Despite the advances in anesthesia and surgical techniques, the duration of mechanical ventilation (MV) may be prolonged after cardiac surgery, due to the classic high-dose narcotic-based cardiac anesthesia.
Detailed description
In recent years, fast-track extubation (FTE) protocols have been developed to reduce the long period of intubation and complications that may occur due to the long duration of MV. Potential advantages of FTE protocols following surgery for congenital cardiac disease are reduced ventilator-associated pulmonary complications and the negative effects of positive pressure ventilation, reduced nosocomial infections, postoperative atelectasis, reduced requirements of sedatives and analgesic drugs, early enteral feeding, rapid patient mobilization, and shorter intensive care unit (ICU) stay.
The ideal analgesic-sedative agents would keep the patient comfortable without anxiety. It would effectively provide adequate sedation, but also allow neurologic evaluation of the patient, ideally without stopping administration of the drug. It would have minimal hemodynamic and respiratory depressant effects. It also would have a rapid onset and offset of action without drug accumulation or active metabolites, making it easily titratable and allowing rapid recovery with a prompt return to normal activity after discontinuation.
Opioids and benzodiazepines are the most frequently used analgesic-sedative agents after cardiac surgery. Although opioid can provide excellent analgesia, the doses for effective pain relief may lead to undesirable side effects, such as respiratory depression requiring prolonged MV, hemodynamic instability, tolerance, and significant withdrawal symptoms that also delay patient recovery.
Dexmedetomidine is a highly selective α2-adrenoreceptor agonist. Presynaptic activation of α2-adrenoreceptors at sympathetic nerve endings inhibits catecholamine release. The major effect of dexmedetomidine is maintaining sedation-analgesia without a respiratory depressant effect. It has relatively few cardiovascular side effects and produces sleep-like sedation without narcosis or respiratory depression.
Indeed, current guidelines recommend lighter levels of sedation to manage ventilated patients preferably using nonbenzodiazepine sedatives. Nevertheless, there is currently no consistent recommendation regarding which nonbenzodiazepine sedative agents should be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidineThis Group about 30 patients will receive a loading dose of 1 μg/kg dexmedetomidine (Precedex 4 mcg/ml, Pfizer. Inc, New York, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2-0.7 μg/kg/h. |
| Fentanyl Group | Experimental | Drug: DexmedetomidineThis Group about 30 patients will receive an initial bolus dose of fentanyl (fentanyl 50 mcg/ml, hameln; Netherlands) of 1-2 μg/kg, followed by an infusion at an initial rate of 1 to 2 μg/kg/h. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study will include patients undergoing elective adult valvular cardiac surgeries
Key exclusion criteria (6 listed)
- Patient refusal.
- Emergent valve cardiac surgeries.
- Patients with known hypersensitivity to study drugs.
- History of uncontrolled diabetes or hypertension.
- Impaired kidney or liver functions.
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 |
|---|---|---|
| DexmedetomidineAlso: fentanyl 50 mcg/mlto investigate the postoperative analgesic-sedative effect of dexmedetomidine versus fentanyl-midazolam to achieve fast-track extubation after adult valvular cardiac surgeries. | Drug | Dexmedetomidine Group, Fentanyl Group |
Primary outcome
Pain Relieve
Time frame: 2 hours post operative
Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed Ibrahim Mohammed Hashish, Professor study chair
Al-Azhar University, Faculty of medicine
Mohamed husseiny Mahmoud, Lecturer principal investigator
Cardio-Thoracic Surgery Department, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Valvular Cardiac Surgeries, run by Egymedicalpedia 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 1 inclusion and 6 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 18 Jun 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.
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 Ahmed Ramadan Ibrahim, MSC (+201002749797, 782014arar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relieve (time frame: 2 hours post operative). 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 18 Jun 2024.