Surgical HemostasisPhase 3FESS (FunctionNCT07013955
Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization
A Phase 3 study testing Saline, Dexmedetomidine and Midazolam in people with Surgical Hemostasis, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this interventional study is to compare the nasal packing with dexmedetomidine .midazolam or bupivacaine on surgical field visualization during FESS . Study groups : Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Surgical Hemostasis
- What is being tested?
- Saline, Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- both sexes
- aged between 16 and 60 years old
- with BMI up to 30
- with ASA physical status I \& II.
Who cannot join
- Patients with a history of allergy to the study drugs.
- Pregnant and lactating females.
- Patients with severe liver, renal, or cardiac diseases
- Patients with repeated nasal surgeries.
- Patients with psychiatric conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study Between the Effect of Nasal Packing With Dexmedetomidine, Midazolam or Bupivacaine on Surgical Field Visualization During Functional Endoscopic Sinus Surgery .
The goal of this interventional study is to compare the nasal packing with dexmedetomidine .midazolam or bupivacaine on surgical field visualization during FESS . Study groups :
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
Read the detailed description
This study will be conducted in Minia University Hospital This prospective randomized double-blind controlled clinical study will be conducted on 144 adult patients of both sexes, aged between 16 and 60 years old, with BMI up to 30 with ASA physical status I \& II.
Parameters assessed:
- Intraoperative Monitoring:
- Surgical field visualization using the Boezaart scale.
- Hemodynamic changes among the study groups including the heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), and oxygen saturation (SPO2) measured at baseline, (10 min after packing), every 5 mins till the end of the surgery.
- Postoperative Evaluation
- Assess postoperative pain using VAS every 1 hour for the 1st six hours, every 2 hours for 12 hours then every 4 hours till 24 hours postoperatively.
- The sedation score will be assessed using the Ramsay sedation score as VAS intervals.
- Surgeon satisfaction will be assessed by a Likert scale.
- Conditions
- Surgical Hemostasis
- Being tested
- Saline, Dexmedetomidine, Midazolam, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
DexmedetomidineDrug
Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
MidazolamDrug
Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.
BupivacaineDrug
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Group C): (control group) | Placebo comparator | Patients in this group will receive only 5 ml of intranasal saline. Receives: Drug: Saline |
| Group II (Group D) | Active comparator | Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. Receives: Drug: Dexmedetomidine |
| Group III (Group M) | Active comparator | Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline. Receives: Drug: Midazolam |
| Group IV (Group B) | Active comparator | Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
We aim to assess the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in reducing bleeding during FESS operations in patients who require general anesthesia with endotracheal intubation.
Evaluate the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in improving surgical field visualization using the Boezaart Score.
Grade Assessment 0 No bleeding (cadaveric conditions)
- Slight bleeding, no suctioning required
- Slight bleeding, occasional suctioning required
- Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed
- Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed
- Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
Measured: Intraoperative (for 2 hours maximally)
Secondary outcomes (3)
Total requirement of nitroglycerine as a hypotensive agent.
Intraoperative total requirement of nitroglycerine as a hypotensive agent.
Measured: postoperative (at the end of operation after 2 hours )
Comparing the surgeon satisfaction among the study groups.
Surgeon satisfaction will be assessed by a Likert scale Score 1 (very poor) Uncontrollable bleeding Score 2 (poor) Severe bleeding requiring repeated suctioning, with the quality of the field collapsing immediately after suctioning Score 3 (satisfactory) Moderate bleeding requiring intermittent suctioning. Score 4 (good) Partial bleeding, sometimes requiring suctioning the quality of the surgical field was good.
Score 5 (excellent) No bleeding/bloodless field; the surgery field was excellent
Measured: Postoperative (immediately at the end of the surgery )
Hemodynamic changes among the study groups:
2.Hemodynamic changes among the study groups including the heart rate (HR) in beat per minute, systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, mean blood pressure (MAP) in mmHg, and oxygen saturation (SPO2) in percentage measured at baseline, (10 min after packing), every 5 mins till the end of the surgery.
Measured: Intraoperative (baseline then every 5 minutes till the end of surgery )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Apr 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical HemostasisStudies of the same condition, open and under way.
- More trials run by Minia 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline. Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline. Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Rabea Mohammed, Minia University
- Investigators
- Fatma R Mohammed, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013955
- Sponsor's protocol ID
- 1465/02/2025
- Acronym
- FESS (Function
- Status last verified
- Feb 2025
- First submitted
- 16 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with corresponding authors on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Nasal Packing With Dexmedetomidine, Midazolam or Bupivacaine on Surgical Field Visualization During Functional Endoscopic Sinus Surgery .
- ClinicalTrials.gov ID
- NCT07013955
- Acronym / sponsor ID
- FESS (Function / 1465/02/2025
- Conditions
- Surgical Hemostasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (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 goal of this interventional study is to compare the nasal packing with dexmedetomidine .midazolam or bupivacaine on surgical field visualization during FESS . Study groups :
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
Detailed description
This study will be conducted in Minia University Hospital This prospective randomized double-blind controlled clinical study will be conducted on 144 adult patients of both sexes, aged between 16 and 60 years old, with BMI up to 30 with ASA physical status I \& II.
Parameters assessed:
- Intraoperative Monitoring:
- Surgical field visualization using the Boezaart scale.
- Hemodynamic changes among the study groups including the heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), and oxygen saturation (SPO2) measured at baseline, (10 min after packing), every 5 mins till the end of the surgery.
- Postoperative Evaluation
- Assess postoperative pain using VAS every 1 hour for the 1st six hours, every 2 hours for 12 hours then every 4 hours till 24 hours postoperatively.
- The sedation score will be assessed using the Ramsay sedation score as VAS intervals.
- Surgeon satisfaction will be assessed by a Likert scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline. Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline. Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
| Arm | Type | Receives |
|---|---|---|
| Group I (Group C): (control group) | Placebo comparator | Drug: SalinePatients in this group will receive only 5 ml of intranasal saline. |
| Group II (Group D) | Active comparator | Drug: DexmedetomidinePatients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. |
| Group III (Group M) | Active comparator | Drug: MidazolamPatients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline. |
| Group IV (Group B) | Active comparator | Drug: BupivacainePatients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- both sexes
- aged between 16 and 60 years old
- with BMI up to 30
- with ASA physical status I \& II.
Key exclusion criteria (5 listed)
- Patients with a history of allergy to the study drugs.
- Pregnant and lactating females.
- Patients with severe liver, renal, or cardiac diseases
- Patients with repeated nasal surgeries.
- Patients with psychiatric conditions.
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 |
|---|---|---|
| SalineGroup I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline. | Drug | Group I (Group C): (control group) |
| DexmedetomidineGroup II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. | Drug | Group II (Group D) |
| MidazolamGroup III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline. | Drug | Group III (Group M) |
| BupivacaineGroup IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml. | Drug | Group IV (Group B) |
Primary outcome
We aim to assess the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in reducing bleeding during FESS operations in patients who require general anesthesia with endotracheal intubation.
Time frame: Intraoperative (for 2 hours maximally)
Evaluate the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in improving surgical field visualization using the Boezaart Score. Grade Assessment 0 No bleeding (cadaveric conditions) 1. Slight bleeding, no suctioning required 2. Slight bleeding, occasional suctioning required 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
3 secondary outcomes
Total requirement of nitroglycerine as a hypotensive agent.
Time frame: postoperative (at the end of operation after 2 hours )
Comparing the surgeon satisfaction among the study groups.
Time frame: Postoperative (immediately at the end of the surgery )
Hemodynamic changes among the study groups:
Time frame: Intraoperative (baseline then every 5 minutes till the end of surgery )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No. Data is available with corresponding authors on reasonable request
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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.
Fatma R Mohammed, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline, Dexmedetomidine and Midazolam in people with Surgical Hemostasis, run by Minia 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 4 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: enrolling by invitation, as of the sponsor's last update on 10 Jun 2025. 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. Some participants in this study may receive a placebo. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
We aim to assess the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in reducing bleeding during FESS operations in patients who require general anesthesia with endotracheal intubation. (time frame: Intraoperative (for 2 hours maximally)). 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 10 Jun 2025.