Intraoperative BleedingPhase 2/3NCT06427707
The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries.
A Phase 2/3 study testing Intravenous Infusion of propofol, lidocaine, Magnesium sulfate, Intravenous infusion of ketamine, lidocaine, Magnesium sulfate and Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate in people with Intraoperative Bleeding, run by Ain Shams University at 1 site in Egypt.
Trial summary
Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intraoperative Bleeding
- What is being tested?
- Intravenous Infusion of propofol, lidocaine, Magnesium sulfate, Intravenous infusion of ketamine, lidocaine, Magnesium sulfate and Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 31 Oct 2024
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II,
- scheduled for elective nasal surgery
Who cannot join
- Patients with uncontrolled hypertension.
- Patients with cardiac disease.
- Patients with renal, hepatic or cerebral insufficiency.
- Patients with coagulopathy or receiving drugs influencing blood coagulation.
- Anaemia, haemoglobinopathies or polycythemia.
- Pregnancy.
- Patients with known sensitivity to any of the study drug.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate, 69711
Rania M Hussien, MD, 026213948 ext. 202, drrania_maamon@med.asu.edu.eg
Hala S El Ozairy, MD, 01001191199 ext. 202, hala_elozairy@med.asu.edu.eg
About this study
Official title: The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions As an Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. a Randomized Controlled Trial
Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.
Read the detailed description
In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries
- Conditions
- Intraoperative Bleeding
- Being tested
- Intravenous Infusion of propofol, lidocaine, Magnesium sulfate, Intravenous infusion of ketamine, lidocaine, Magnesium sulfate, Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate
- 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.
Intravenous Infusion of propofol, lidocaine, Magnesium sulfateDrug
intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding
Intravenous infusion of ketamine, lidocaine, Magnesium sulfateDrug
Patients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1.
Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfateDrug
Also called Precedex
Dexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1
| Study group | Role | What they receive |
|---|---|---|
| Group PLM (propofol-lidocaine-magnesium) | Active comparator | intravenous infusion of propofol, lidocaine and magnesium sulfate. Receives: Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate |
| Group KLM (ketamine-lidocaine-magnesium) | Active comparator | intravenous infusion of Ketamine, lidocaine and magnesium sulfate Receives: Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate |
| Group DLM (Dexmeditomidine-lidocaine-magnesium) | Active comparator | Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate Receives: Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical field using the average category scale (ACS).
Degree of surgical field bleeding
Measured: During the operation
Secondary outcomes (1)
sedation using Ramsy sedation score
Degree of sedation using Ramsy sedation score
Measured: First hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Jun 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
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 Ain Shams 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427707
- Sponsor's protocol ID
- FMASU R84/2024
- Status last verified
- Oct 2024
- First submitted
- 20 May 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions As an Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06427707
- Acronym / sponsor ID
- FMASU R84/2024
- Conditions
- Intraoperative Bleeding
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 24 May 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.
Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.
Detailed description
In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries.
| Arm | Type | Receives |
|---|---|---|
| Group PLM (propofol-lidocaine-magnesium) | Active comparator | Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfateintravenous infusion of propofol, lidocaine and magnesium sulfate. |
| Group KLM (ketamine-lidocaine-magnesium) | Active comparator | Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfateintravenous infusion of Ketamine, lidocaine and magnesium sulfate |
| Group DLM (Dexmeditomidine-lidocaine-magnesium) | Active comparator | Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfateIntravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I-II,
- scheduled for elective nasal surgery
Key exclusion criteria (7 listed)
- Patients with uncontrolled hypertension.
- Patients with cardiac disease.
- Patients with renal, hepatic or cerebral insufficiency.
- Patients with coagulopathy or receiving drugs influencing blood coagulation.
- Anaemia, haemoglobinopathies or polycythemia.
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 |
|---|---|---|
| Intravenous Infusion of propofol, lidocaine, Magnesium sulfateintravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding | Drug | Group PLM (propofol-lidocaine-magnesium) |
| Intravenous infusion of ketamine, lidocaine, Magnesium sulfatePatients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. | Drug | Group KLM (ketamine-lidocaine-magnesium) |
| Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfateAlso: PrecedexDexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1 | Drug | Group DLM (Dexmeditomidine-lidocaine-magnesium) |
Primary outcome
surgical field using the average category scale (ACS).
Time frame: During the operation
Degree of surgical field bleeding
1 secondary outcome
sedation using Ramsy sedation score
Time frame: First hour postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Related trials for Intraoperative Bleeding
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Active, not recruitingObservational study
Safe and Timely Antithrombotic Removal (STAR) Registry
Hemorrhage, Surgical, Hemorrhage Postoperative
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous Infusion of propofol, lidocaine, Magnesium sulfate, Intravenous infusion of ketamine, lidocaine, Magnesium sulfate and Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate in people with Intraoperative Bleeding, run by Ain Shams 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 2 inclusion and 7 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 9 Oct 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 RANIA M Hussien, MD (01000544520 ext. 202, drrania_maamon@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical field using the average category scale (ACS). (time frame: During the operation). 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 9 Oct 2024.