Intraoperative BleedingNCT06670690
Comparison Between Atenolol,Propnalol and Ivabradine
A study testing Atenolol 50 MG, Propranolol Pill and Ivabradine in people with Intraoperative Bleeding, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Bleeding
- What is being tested?
- Atenolol 50 MG, Propranolol Pill and Ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Oct 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I and II,
- aged from 18 to 50 years old
- scheduled for elective lumber spine surgeries will be included in this study.
Who cannot join
- Hypertension.
- Hepatic or renal disease.
- Diabetes Mellitus.
- Pregnancy.
- Coagulation disorders.
- Anemia (Hb < 10 g/dL).
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- Ischemic heart disease
- Drug or alcohol abuse.
- Allergy to any of atenolol, propranolol, and ivabradine.
- History of beta-blockers, calcium channel blockers, Tricyclic antidepressants, anticoagulant or clonidine intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Atenolol , Propnalol and Ivabradine as a Premedication for Bloodless Field Anesthesia in Lumbar Spine Surgery ,a Prospective Randomized Controlled Trial
The aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
Read the detailed description
This study will investigate the effect of atenolol, propranolol, and ivabradine as oral premedication in adult patients undergoing LUMBAR SPINE SURGERY to achieve bloodless field anesthesia.
AIM OF THE WORK
- The primary aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
- The secondary aims are to assess field visibility and measure the amount of blood loss in patients, and surgeon satisfaction and also to asses if there are any associated undesirable side effects of atenolol, propranolol, or Ivabradine will appear.
- Conditions
- Intraoperative Bleeding
- Being tested
- Atenolol 50 MG, Propranolol Pill, Ivabradine
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atenolol 50 MGDrug
patients will be premedicated with atenolol (50mg)
Propranolol PillDrug
patients will be premedicated with propranolol (10mg)
IvabradineDrug
patients will be premedicated with Ivabradine (5mg)
| Study group | Role | What they receive |
|---|---|---|
| Atenolol Group | Active comparator | patients will be premedicated with atenolol (50mg) Receives: Drug: Atenolol 50 MG |
| propranolol Group | Active comparator | patients will be premedicated with propranolol (10mg) Receives: Drug: Propranolol Pill |
| Ivabradine Group | Active comparator | patients will be premedicated with Ivabradine (5mg) Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Heamodynamic Effect of the drugs
Heart rate
Measured: every 5 minutes for 15 minutes and then every 10 minutes till end of surgery, then every 15 minutes for 1hour in the recovery room
Secondary outcomes (4)
Blood loss & surgical field visibility score
quality scale proposed by Fromm and Boezaart
Measured: Intraoperative time
Anesthetic consumption
Propofol, opioid, and isoflurane consumption
Measured: Intraoperative time
Incidence of complication
The patient will be examined for bradycardia, or tachycardia hypo or hypertension, shivering, respiratory depression, dizziness, visual disturbance, nausea, and vomiting
Measured: Intraoperative time
The need for blood transfusion
The need for blood transfusion
Measured: Intraoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative BleedingStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670690
- Sponsor's protocol ID
- 9/2023ANET 13
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Atenolol , Propnalol and Ivabradine as a Premedication for Bloodless Field Anesthesia in Lumbar Spine Surgery ,a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06670690
- Acronym / sponsor ID
- 9/2023ANET 13
- Conditions
- Intraoperative Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 1 Nov 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.
The aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
Detailed description
This study will investigate the effect of atenolol, propranolol, and ivabradine as oral premedication in adult patients undergoing LUMBAR SPINE SURGERY to achieve bloodless field anesthesia.
AIM OF THE WORK
- The primary aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
- The secondary aims are to assess field visibility and measure the amount of blood loss in patients, and surgeon satisfaction and also to asses if there are any associated undesirable side effects of atenolol, propranolol, or Ivabradine will appear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atenolol Group | Active comparator | Drug: Atenolol 50 MGpatients will be premedicated with atenolol (50mg) |
| propranolol Group | Active comparator | Drug: Propranolol Pillpatients will be premedicated with propranolol (10mg) |
| Ivabradine Group | Active comparator | Drug: Ivabradinepatients will be premedicated with Ivabradine (5mg) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I and II,
Key exclusion criteria (10 listed)
- Hypertension.
- Hepatic or renal disease.
- Diabetes Mellitus.
- Pregnancy.
- Coagulation disorders.
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 |
|---|---|---|
| Atenolol 50 MGpatients will be premedicated with atenolol (50mg) | Drug | Atenolol Group |
| Propranolol Pillpatients will be premedicated with propranolol (10mg) | Drug | propranolol Group |
| Ivabradinepatients will be premedicated with Ivabradine (5mg) | Drug | Ivabradine Group |
Primary outcome
Perioperative Heamodynamic Effect of the drugs
Time frame: every 5 minutes for 15 minutes and then every 10 minutes till end of surgery, then every 15 minutes for 1hour in the recovery room
Heart rate
4 secondary outcomes
Blood loss & surgical field visibility score
Time frame: Intraoperative time
Anesthetic consumption
Time frame: Intraoperative time
Incidence of complication
Time frame: Intraoperative time
The need for blood transfusion
Time frame: Intraoperative time
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 1 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Atenolol 50 MG, Propranolol Pill and Ivabradine in people with Intraoperative Bleeding, run by Menoufia 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 3 inclusion and 10 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 1 Nov 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?
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?
Perioperative Heamodynamic Effect of the drugs (time frame: every 5 minutes for 15 minutes and then every 10 minutes till end of surgery, then every 15 minutes for 1hour in the recovery room). 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 Nov 2024.