Nasal BleedingPhase 2/3NCT06801522
Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation
A Phase 2/3 study testing 0.1% xylometazoline nasal drops and Adrenaline nasal pack in people with Nasal Bleeding and Nasotracheal Intubation, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
The goal of this trial is to compare efficacy of xylometazoline nasal drops and adrenaline nasal pack in participants undergoing elective oromaxillofacial surgeries. The main question aim to answer is xylometazoline nasal drops better than adrenaline nasal packing in terms of nasal bleeding during nasotracheal… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Bleeding, Nasotracheal Intubation
- What is being tested?
- 0.1% xylometazoline nasal drops and Adrenaline nasal pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2024to May 2025
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1 and 2
- Age group between 18-60 years
- Mallampati score 1 and 2
- Either gender
- Participants who undergo elective oromaxillofacial surgery
Who cannot join
- Lack of consent
- Participants with anticipated difficult airway
- Participants receiving anticoagulant therapy
- History of nasal abnormality (nasal surgery, trauma, polyp, obstruction)
- History of repeated epistaxis
- History of uncontrolled hypertension, diabetes, pregnancy, and any other cardiac or cerebral events.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW contact
Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS, MCPS, FCPS contact
Pakistan1 site, 1 recruiting
- Recruiting
Shaheed Mohtarma Benazir Bhutto Institute of Trauma
Karachi, Sindh
Iqra Ashraf, MBBS, FCPS TRAINEE
Sidra Tahir, MBBS, FCPS TRAINEE
About this study
Official title: Comparison of the Efficacy of Adrenaline Nasal Pack and Xylometazoline Nasal Drops in Decreasing Nasal Bleeding During Nasotracheal Intubation
The goal of this trial is to compare efficacy of xylometazoline nasal drops and adrenaline nasal pack in participants undergoing elective oromaxillofacial surgeries.
The main question aim to answer is xylometazoline nasal drops better than adrenaline nasal packing in terms of nasal bleeding during nasotracheal intubation. Researchers are comparing 2 groups of participants.
Participants in group Xylometazoline are receiving 0.1% xylometaxoline nasal drops.
Participants in group Adrenaline are receiving adrenaline nasal packing.
Read the detailed description
This study is conducting after permission from institutional ethical committee. Participants came for elective OMF surgery under general anesthesia are enrolled in this study who fulfilled the inclusion criteria. Informed consent is taken from the participants. Brief history about demographic data was taken from each participant. All participants are examined for airway assessment, cardiovascular and respiratory examination before undergoing anesthesia. Participants are divided into 2 groups by simple lottery method in group xylometazoline and group adrenaline.
Group Xylometazoline: receive 3 to 5 drops of 0.1% xylometazoline nasal drops in selected nostril 15 mins before transfer to OT.
Group Adrenaline: receive intranasal packing with adrenaline soaked gauze piece in selected nostril. Packing is done 15 mins before transfer to OT and removed after 7 to 10 minutes. Proper monitoring of vital signs will be done in preoperative area.
Anesthesia machine and accessories are checked, and drugs including emergency drugs are kept ready. Baseline BP, heart rate, ECG, and peripheral oxygen saturation is obtained and recorded from multipara monitor. All participants are preoxygenated by 100% oxygen for 5 mins. Induction is done with propofol (1%) 2mg/kg and atracurium 0.5 mg/kg by senior anesthesiologist present. The anesthetist present in OT is blind to both groups. Laryngoscopy is done by an experienced anesthesiologist using a MAC 3 or 4 blade based on participants' anatomy. Nasotracheal intubation is done by a cuffed lubricated (with lidocaine 2%) nasal tube of appropriate size. Anesthesia is maintained with atracurium 0.1 mg/kg and isoflurane in 60% O2 at 3L flow.
The anesthesiologist will record incidence and severity of bleeding at the time of intubation and extubation.
Data will be analyzed on SPSS version 20. Chi square test will be used to compare the incidence of nasal bleeding in both groups. Effect modifiers are controlled through stratification of age, gender, diabetes mellitus, hypertension to see the effect of these on the outcome variables. Post stratification chi square test will be applied taking P-value of <0.05 as statistically significant.
- Conditions
- Nasal Bleeding, Nasotracheal Intubation
- Being tested
- 0.1% xylometazoline nasal drops, Adrenaline nasal pack
- Keywords
- Nasal bleeding, Nasotracheal intubation, adrenaline pack, xylometazoline nasal drops
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% xylometazoline nasal dropsDrug
Xylometazoline is direct acting, non selective, adrenergic agonist binding with alpha 1\&2 receptors, used for vasoconstriction to decrease nasal bleeding.
Adrenaline nasal packDrug
Adrenaline is direct acting, non selective, adrenergic agonist binding with alpha and beta receptors both, used for vasoconstriction to decrease nasal bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Xylometazoline Group | Experimental | Participants in this group will receive xylometazoline nasal drops before nasotracheal intubation Receives: Drug: 0.1% xylometazoline nasal drops |
| Adrenaline Group | Active comparator | Participants in this group will recieve adrenaline nasal packing before nasotracheal intubation Receives: Drug: Adrenaline nasal pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal bleeding
Measured: At the time of Intubation and Extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Dec 2024
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasal 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
- Group Xylometazoline will receive xylometazoline nasal drops and Group Adrenaline will receive adrenaline nasal pack
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IQRA ASHRAF, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801522
- Sponsor's protocol ID
- ERC-000104/SMBBIT/2023
- Status last verified
- Dec 2024
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Confidentialit: Sharing IPD could compromise patient confidentiality and anonymity. Informed consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
Publications
Sato-Boku A, Sento Y, Kamimura Y, Kako E, Okuda M, Tachi N, Okumura Y, Hashimoto M, Hoshijima H, Suzuki F, Sobue K. Comparison of hemostatic effect and safety between epinephrine and tramazoline during nasotracheal intubation: a double-blind randomized trial. BMC Anesthesiol. 2021 Sep 30;21(1):235. doi: 10.1186/s12871-021-01454-y.
PubMed 34592949Ozkan ASM, Akbas S, Toy E, Durmus M. North Polar Tube Reduces the Risk of Epistaxis during Nasotracheal Intubation: A prospective, Randomized Clinical Trial. Curr Ther Res Clin Exp. 2018 Oct 9;90:21-26. doi: 10.1016/j.curtheres.2018.09.002. eCollection 2019.
PubMed 30787962Earle R, Shanahan E, Vaghadia H, Sawka A, Tang R. Epistaxis during nasotracheal intubation: a randomized trial of the Parker Flex-Tip nasal endotracheal tube with a posterior facing bevel versus a standard nasal RAE endotracheal tube. Can J Anaesth. 2017 Apr;64(4):370-375. doi: 10.1007/s12630-017-0813-4. Epub 2017 Jan 11.
PubMed 28078544Song J. A comparison of the effects of epinephrine and xylometazoline in decreasing nasal bleeding during nasotracheal intubation. J Dent Anesth Pain Med. 2017 Dec;17(4):281-287. doi: 10.17245/jdapm.2017.17.4.281. Epub 2017 Dec 28.
PubMed 29349350Patel S, Hazarika A, Agrawal P, Jain D, Panda NK. A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation. J Dent Anesth Pain Med. 2020 Aug;20(4):223-231. doi: 10.17245/jdapm.2020.20.4.223. Epub 2020 Aug 27.
PubMed 32934988
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Adrenaline Nasal Pack and Xylometazoline Nasal Drops in Decreasing Nasal Bleeding During Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT06801522
- Acronym / sponsor ID
- ERC-000104/SMBBIT/2023
- Conditions
- Nasal Bleeding, Nasotracheal Intubation
- Keywords
- Nasal bleeding, Nasotracheal intubation, adrenaline pack, xylometazoline nasal drops
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 30 Jan 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 trial is to compare efficacy of xylometazoline nasal drops and adrenaline nasal pack in participants undergoing elective oromaxillofacial surgeries.
The main question aim to answer is xylometazoline nasal drops better than adrenaline nasal packing in terms of nasal bleeding during nasotracheal intubation. Researchers are comparing 2 groups of participants.
Participants in group Xylometazoline are receiving 0.1% xylometaxoline nasal drops.
Participants in group Adrenaline are receiving adrenaline nasal packing.
Detailed description
This study is conducting after permission from institutional ethical committee. Participants came for elective OMF surgery under general anesthesia are enrolled in this study who fulfilled the inclusion criteria. Informed consent is taken from the participants. Brief history about demographic data was taken from each participant. All participants are examined for airway assessment, cardiovascular and respiratory examination before undergoing anesthesia. Participants are divided into 2 groups by simple lottery method in group xylometazoline and group adrenaline.
Group Xylometazoline: receive 3 to 5 drops of 0.1% xylometazoline nasal drops in selected nostril 15 mins before transfer to OT.
Group Adrenaline: receive intranasal packing with adrenaline soaked gauze piece in selected nostril. Packing is done 15 mins before transfer to OT and removed after 7 to 10 minutes. Proper monitoring of vital signs will be done in preoperative area.
Anesthesia machine and accessories are checked, and drugs including emergency drugs are kept ready. Baseline BP, heart rate, ECG, and peripheral oxygen saturation is obtained and recorded from multipara monitor. All participants are preoxygenated by 100% oxygen for 5 mins. Induction is done with propofol (1%) 2mg/kg and atracurium 0.5 mg/kg by senior anesthesiologist present. The anesthetist present in OT is blind to both groups. Laryngoscopy is done by an experienced anesthesiologist using a MAC 3 or 4 blade based on participants' anatomy. Nasotracheal intubation is done by a cuffed lubricated (with lidocaine 2%) nasal tube of appropriate size. Anesthesia is maintained with atracurium 0.1 mg/kg and isoflurane in 60% O2 at 3L flow.
The anesthesiologist will record incidence and severity of bleeding at the time of intubation and extubation.
Data will be analyzed on SPSS version 20. Chi square test will be used to compare the incidence of nasal bleeding in both groups. Effect modifiers are controlled through stratification of age, gender, diabetes mellitus, hypertension to see the effect of these on the outcome variables. Post stratification chi square test will be applied taking P-value of <0.05 as statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group Xylometazoline will receive xylometazoline nasal drops and Group Adrenaline will receive adrenaline nasal pack
| Arm | Type | Receives |
|---|---|---|
| Xylometazoline Group | Experimental | Drug: 0.1% xylometazoline nasal dropsParticipants in this group will receive xylometazoline nasal drops before nasotracheal intubation |
| Adrenaline Group | Active comparator | Drug: Adrenaline nasal packParticipants in this group will recieve adrenaline nasal packing before nasotracheal intubation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA 1 and 2
- Age group between 18-60 years
- Mallampati score 1 and 2
- Either gender
- Participants who undergo elective oromaxillofacial surgery
Key exclusion criteria (6 listed)
- Lack of consent
- Participants with anticipated difficult airway
- Participants receiving anticoagulant therapy
- History of nasal abnormality (nasal surgery, trauma, polyp, obstruction)
- History of repeated epistaxis
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 |
|---|---|---|
| 0.1% xylometazoline nasal dropsXylometazoline is direct acting, non selective, adrenergic agonist binding with alpha 1\&2 receptors, used for vasoconstriction to decrease nasal bleeding. | Drug | Xylometazoline Group |
| Adrenaline nasal packAdrenaline is direct acting, non selective, adrenergic agonist binding with alpha and beta receptors both, used for vasoconstriction to decrease nasal bleeding. | Drug | Adrenaline Group |
Primary outcome
Nasal bleeding
Time frame: At the time of Intubation and Extubation
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 30 Jan 2025.
- Results publication: PubMed 34592949Sato-Boku A, Sento Y, Kamimura Y, Kako E, Okuda M, Tachi N, Okumura Y, Hashimoto M, Hoshijima H, Suzuki F, Sobue K. Comparison of hemostatic effect and safety between epinephrine and tramazoline during nasotracheal intubation: a double-blind randomized trial. BMC Anesthesiol. 2021 Sep 30;21(1):235. doi: 10.1186/s12871-021-01454-y.
- Results publication: PubMed 30787962Ozkan ASM, Akbas S, Toy E, Durmus M. North Polar Tube Reduces the Risk of Epistaxis during Nasotracheal Intubation: A prospective, Randomized Clinical Trial. Curr Ther Res Clin Exp. 2018 Oct 9;90:21-26. doi: 10.1016/j.curtheres.2018.09.002. eCollection 2019.
- Results publication: PubMed 28078544Earle R, Shanahan E, Vaghadia H, Sawka A, Tang R. Epistaxis during nasotracheal intubation: a randomized trial of the Parker Flex-Tip nasal endotracheal tube with a posterior facing bevel versus a standard nasal RAE endotracheal tube. Can J Anaesth. 2017 Apr;64(4):370-375. doi: 10.1007/s12630-017-0813-4. Epub 2017 Jan 11.
- Results publication: PubMed 29349350Song J. A comparison of the effects of epinephrine and xylometazoline in decreasing nasal bleeding during nasotracheal intubation. J Dent Anesth Pain Med. 2017 Dec;17(4):281-287. doi: 10.17245/jdapm.2017.17.4.281. Epub 2017 Dec 28.
- Results publication: PubMed 32934988Patel S, Hazarika A, Agrawal P, Jain D, Panda NK. A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation. J Dent Anesth Pain Med. 2020 Aug;20(4):223-231. doi: 10.17245/jdapm.2020.20.4.223. Epub 2020 Aug 27.
- Individual participant dataSharing planned: No. Patient Confidentialit: Sharing IPD could compromise patient confidentiality and anonymity. Informed consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
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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.
Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW contact
Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS, MCPS, FCPS contact
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 0.1% xylometazoline nasal drops and Adrenaline nasal pack in people with Nasal Bleeding and Nasotracheal Intubation, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
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 5 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: looking for participants now, as of the sponsor's last update on 30 Jan 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 Pakistan. 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?
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?
Contact Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW (+92333 2474831, sidra_dow@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal bleeding (time frame: At the time of Intubation and Extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801522, which also lists 5 linked publications.
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 30 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.