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
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. Contact the study team or a site near you to ask about taking part.
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.
- 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