Patients Undergoing Rigid BronchoscopyPhase 4NCT07409935
A Comparative Study Between Combination of Propofol and Dexmedetomidine Versus Propofol Alone in Anesthesia for Rigid Bronchoscopy by Using the Patient State Index Monitor
A Phase 4 study testing Propofol saline and Propofol Dexmedetomidine in people with Patients Undergoing Rigid Bronchoscopy, run by Cairo University at 1 site in Egypt.
Trial summary
Standard ASA fasting guidelines will be followed. IV 20 gauge cannula will be inserted and dedicated to the infusion drugs. Standard ASA monitors will be attached, and baseline heart rate (HR), mean arterial blood pressure (MAP), and oxygen saturation (SpO2) will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients Undergoing Rigid Bronchoscopy
- What is being tested?
- Propofol saline and Propofol Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Oct 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 - 60 years, scheduled for elective rigid bronchoscopy procedure.
- ASA physical status I-II
- Both genders.
Who cannot join
- Patient refusal.
- Known allergy to any of the used drugs.
- Bleeding disorders.
- Hemodynamically unstable patients ( mean arterial blood pressure [MAP] < 60 mmHg).
- Tracheostomy tube in situ.
- Patients with stridor and any upper airway emergency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Combination of Propofol and Dexmedetomidine Versus Propofol Alone in Anesthesia for Rigid Bronchoscopy by Using the Patient State Index Monitor (PSI): A Randomized Controlled Study
Standard ASA fasting guidelines will be followed. IV 20 gauge cannula will be inserted and dedicated to the infusion drugs. Standard ASA monitors will be attached, and baseline heart rate (HR), mean arterial blood pressure (MAP), and oxygen saturation (SpO2) will be recorded. The SedLine Brain Function Monitor's electrode (Masimo O3™, Masimo corporation, Irvine, California, USA) will be positioned on the patient's forehead.
Fifty Patients will be involved in this study and randomized into two groups: 25 patients as propofol/dexmedetomidine (PD) group and another 25 patients as propofol/saline (PS) group. The PD group will receive dexmedetomidine 0.5 µ/kg bolus over 10 min before induction of anesthesia followed by a continuous infusion of (0.5 µ/kg/h) throughout the procedure . PS group will receive normal saline infusion over 10 min before induction of anesthesia and then throughout the procedure with an infusion rate adjusted to match dexmedetomidine infusion in PD group.
Read more
Anesthesia protocol, Induction of anesthesia in all patients will be done with 1% IV propofol (2 mg/kg), and IV fentanyl (2 µ/kg), IV atracurium (0.5mg/kg). Ventilation will be achieved by face mask until introduction of RB. When RB is introduced, rapid manual jet ventilation by venturi technique, In case of hypoxemia (SPO2 < 90%), bronchoscope will be used as an endotracheal tube by occluding the main port of bronchoscope and patient will be ventilated by providing intermittent positive pressure ventilation. In case of persistent hypoxemia despite adequate jet ventilation, RB will be withdrawn followed by endotracheal intubation and mechanical ventilation. Anesthesia is maintained by propofol infusion started in both groups in 4 mg/kg/h. Rate of propofol infusion will be adjusted to maintain PSI between 25-50 in order to ensure adequate depth of anesthesia. After insertion of RB above the level of carina and before proceeding to the desired bronchus, 2% lidocaine 2-3 ml will be instilled in the targeted bronchus through suction port. Hydrocortisone 100 mg will be given to minimize laryngeal edema.
At the end of the procedure, RB will be removed and replaced with a regular endotracheal tube to secure the airway, infusions will be stopped and muscle relaxation will be reversed by using neostigmine and atropine when clinically observed that it is proper timing. After end of procedure, Modified Observer's Assessment of Alertness/Sedation scale (MOAAS) will be recorded every 10 min after bronchoscopy removal. The following descriptions of MOAAS scores will be used: 0 does not respond to pain; 1 does not respond to mild prodding or shaking; 2 responds after mild prodding or shaking; 3 responds after calling loudly or repeatedly; 4 responds slowly to voice with normal tone; 5 responds readily to voice with normal tone. Patients will be transferred to the post anesthesia care unit (PACU) when MOAAS scale in between 4 and 5. They will be observed for 2-3 h in PACU for complications and hemodynamic changes, The patient will be asked if he remember anything between going to sleep and waking by using modified Brice questionnaire: 1. What was the last thing you remembered before going to sleep? 2. What was the first thing you remembered on waking? 3. Do you remember anything between going to sleep and waking? 4. While you were sleeping during the operation, did you dream?.
- Conditions
- Patients Undergoing Rigid Bronchoscopy
- Being tested
- Propofol saline, Propofol Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol salineDrug
Also called Rigid bronchoscopy, Patient State Index monitor, manual jet ventilation, Modified Observer's Assessment of Alertness/Sedation scale
25 Patients were assigned propofol/saline (PS) group. The PS group received normal saline infusion over 10 min before induction of anesthesia and then throughout the procedure with an infusion rate adjusted to match dexmedetomidine infusion in propofol/dexmedetomidine (PD) group. Induction of anesthesia in all patients was done with 1% IV propofol (2 mg/kg), and IV fentanyl (2 µ/kg), IV atracurium (0.5mg/kg). Ventilation was achieved by face mask . When RB was introduced, rapid manual jet ventilation by venturi technique. Anesthesia was maintained by propofol infusion started in both groups in 4 mg/kg/h. Rate of propofol infusion was adjusted to maintain PSI between 25-50 in order to ensure adequate depth of anesthesia. At the end of the procedure, RB was removed and replaced with a regular endotracheal tube to secure the airway, infusions stopped and muscle relaxation reversed by using neostigmine and atropine when clinically observed that it was proper timing.
Propofol DexmedetomidineDrug
Also called Rigid bronchoscopy, manuel jet ventilation, Patient State Index, Modified Observer's Assessment of Alertness/Sedation scale
25 Patients were involved as propofol/dexmedetomidine (PD) group. The PD group received dexmedetomidine 0.5 µ/kg bolus over 10 min before induction of anesthesia followed by a continuous infusion of (0.5 µ/kg/h) throughout the procedure. Induction of anesthesia in all patients was done with 1% IV propofol (2 mg/kg), and IV fentanyl (2 µ/kg), IV atracurium (0.5mg/kg). Ventilation was achieved by face mask . When RB was introduced, rapid manual jet ventilation by venturi technique. Anesthesia was maintained by propofol infusion started in both groups in 4 mg/kg/h. Rate of propofol infusion was adjusted to maintain PSI between 25-50 in order to ensure adequate depth of anesthesia. At the end of the procedure, RB was removed and replaced with a regular endotracheal tube to secure the airway, infusions stopped and muscle relaxation was reversed by using neostigmine and atropine when clinically observed that it was proper timing.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Saline | Other | Not described Receives: Drug: Propofol saline |
| Propofol Dexmedetomidine | Other | Not described Receives: Drug: Propofol Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean heart rate value
Mean heart rate measured after rigid bronchoscopy insertion while maintaining adequate depth of anesthesia
Measured: During the intraoperative period, assessed at 5 minutes after rigid bronchoscopy insertion
Secondary outcomes (6)
Incidence of intraoperative hypotension
Hypotension defined as mean arterial blood pressure < 60 mmHg occurring during the perioperative period.
Measured: During the intraoperative and immediate postoperative period (from induction of anesthesia until discharge from the post-anesthesia care unit)
Use of vasopressors for treatment of hypotension
Administration of intravenous ephedrine (2.5-5 mg boluses every 3-5 minutes) for treatment of hypotension (mean arterial blood pressure < 60 mmHg)
Measured: During the intraoperative and immediate postoperative period (from induction of anesthesia until discharge from the post-anesthesia care unit)
Total dose of propofol used intraoperatively
Total dose of propofol administered (in milligrams) during the procedure from induction of anesthesia until the end of rigid bronchoscopy
Measured: From induction of anesthesia until the end of the rigid bronchoscopy procedure
Time to recovery of consciousness
Time taken from discontinuation of anesthetic infusions until achieving a Modified Observer's Assessment of Alertness/Sedation (MOAAS) score ≥ 4
Measured: From discontinuation of anesthetic infusions until achievement of MOAAS score ≥ 4 in the post-anesthesia care unit
Incidence of intraoperative awareness
Incidence of awareness during anesthesia assessed using the modified Brice questionnaire
Measured: Assessed within 2-3 hours postoperatively in the post-anesthesia care unit
Type and incidence of postoperative complications
Incidence and type of postoperative complications including delirium, hypoxia, nausea, and vomiting
Measured: During the post-anesthesia care unit stay (up to 2-3 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Apr 2024
- Primary completion1 Apr 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Rigid BronchoscopyStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Nashaat Shawky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409935
- Sponsor's protocol ID
- MD-38-2024
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Combination of Propofol and Dexmedetomidine Versus Propofol Alone in Anesthesia for Rigid Bronchoscopy by Using the Patient State Index Monitor (PSI): A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07409935
- Acronym / sponsor ID
- MD-38-2024
- Conditions
- Patients Undergoing Rigid Bronchoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 13 Feb 2026 (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.
Standard ASA fasting guidelines will be followed. IV 20 gauge cannula will be inserted and dedicated to the infusion drugs. Standard ASA monitors will be attached, and baseline heart rate (HR), mean arterial blood pressure (MAP), and oxygen saturation (SpO2) will be recorded. The SedLine Brain Function Monitor's electrode (Masimo O3™, Masimo corporation, Irvine, California, USA) will be positioned on the patient's forehead.
Fifty Patients will be involved in this study and randomized into two groups: 25 patients as propofol/dexmedetomidine (PD) group and another 25 patients as propofol/saline (PS) group. The PD group will receive dexmedetomidine 0.5 µ/kg bolus over 10 min before induction of anesthesia followed by a continuous infusion of (0.5 µ/kg/h) throughout the procedure . PS group will receive normal saline infusion over 10 min before induction of anesthesia and then throughout the procedure with an infusion rate adjusted to match dexmedetomidine infusion in PD group.
Anesthesia protocol, Induction of anesthesia in all patients will be done with 1% IV propofol (2 mg/kg), and IV fentanyl (2 µ/kg), IV atracurium (0.5mg/kg). Ventilation will be achieved by face mask until introduction of RB. When RB is introduced, rapid manual jet ventilation by venturi technique, In case of hypoxemia (SPO2 < 90%), bronchoscope will be used as an endotracheal tube by occluding the main port of bronchoscope and patient will be ventilated by providing intermittent positive pressure ventilation. In case of persistent hypoxemia despite adequate jet ventilation, RB will be withdrawn followed by endotracheal intubation and mechanical ventilation. Anesthesia is maintained by propofol infusion started in both groups in 4 mg/kg/h. Rate of propofol infusion will be adjusted to maintain PSI between 25-50 in order to ensure adequate depth of anesthesia. After insertion of RB above the level of carina and before proceeding to the desired bronchus, 2% lidocaine 2-3 ml will be instilled in the targeted bronchus through suction port. Hydrocortisone 100 mg will be given to minimize laryngeal edema.
At the end of the procedure, RB will be removed and replaced with a regular endotracheal tube to secure the airway, infusions will be stopped and muscle relaxation will be reversed by using neostigmine and atropine when clinically observed that it is proper timing. After end of procedure, Modified Observer's Assessment of Alertness/Sedation scale (MOAAS) will be recorded every 10 min after bronchoscopy removal. The following descriptions of MOAAS scores will be used: 0 does not respond to pain; 1 does not respond to mild prodding or shaking; 2 responds after mild prodding or shaking; 3 responds after calling loudly or repeatedly; 4 responds slowly to voice with normal tone; 5 responds readily to voice with normal tone. Patients will be transferred to the post anesthesia care unit (PACU) when MOAAS scale in between 4 and 5. They will be observed for 2-3 h in PACU for complications and hemodynamic changes, The patient will be asked if he remember anything between going to sleep and waking by using modified Brice questionnaire: 1. What was the last thing you remembered before going to sleep? 2. What was the first thing you remembered on waking? 3. Do you remember anything between going to sleep and waking? 4. While you were sleeping during the operation, did you dream?.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Saline | Other | Drug: Propofol saline |
| Propofol Dexmedetomidine | Other | Drug: Propofol Dexmedetomidine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18 - 60 years, scheduled for elective rigid bronchoscopy procedure.
- ASA physical status I-II
- Both genders.
Key exclusion criteria (6 listed)
- Patient refusal.
- Known allergy to any of the used drugs.
- Bleeding disorders.
- Hemodynamically unstable patients ( mean arterial blood pressure [MAP] < 60 mmHg).
- Tracheostomy tube in situ.
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 |
|---|---|---|
| Propofol salineAlso: Rigid bronchoscopy, Patient State Index monitor, manual jet ventilation, Modified Observer's Assessment of Alertness/Sedation scale25 Patients were assigned propofol/saline (PS) group. The PS group received normal saline infusion over 10 min before induction of anesthesia and then throughout the procedure with an infusion rate adjusted to match dexmedetomidine infusion in propofol/dexmedetomidine (PD) group. Induction of anesthesia in all patients was done with 1% IV propofol (2 mg/kg), and IV fentanyl (2 µ/kg), IV atracurium (0.5mg/kg). Ventilation was achieved by face mask . When RB was introduced, rapid manual jet ventilation by venturi technique. Anesthesia was maintained by propofol infusion started in both groups in 4 mg/kg/h. Rate of propofol infusion was adjusted to maintain PSI between 25-50 in order to ensure adequate depth of anesthesia. At the end of the procedure, RB was removed and replaced with a regular endotracheal tube to secure the airway, infusions stopped and muscle relaxation reversed by using neostigmine and atropine when clinically observed that it was proper timing. | Drug | Propofol Saline |
| Propofol DexmedetomidineAlso: Rigid bronchoscopy, manuel jet ventilation, Patient State Index, Modified Observer's Assessment of Alertness/Sedation scale25 Patients were involved as propofol/dexmedetomidine (PD) group. The PD group received dexmedetomidine 0.5 µ/kg bolus over 10 min before induction of anesthesia followed by a continuous infusion of (0.5 µ/kg/h) throughout the procedure. Induction of anesthesia in all patients was done with 1% IV propofol (2 mg/kg), and IV fentanyl (2 µ/kg), IV atracurium (0.5mg/kg). Ventilation was achieved by face mask . When RB was introduced, rapid manual jet ventilation by venturi technique. Anesthesia was maintained by propofol infusion started in both groups in 4 mg/kg/h. Rate of propofol infusion was adjusted to maintain PSI between 25-50 in order to ensure adequate depth of anesthesia. At the end of the procedure, RB was removed and replaced with a regular endotracheal tube to secure the airway, infusions stopped and muscle relaxation was reversed by using neostigmine and atropine when clinically observed that it was proper timing. | Drug | Propofol Dexmedetomidine |
Primary outcome
Mean heart rate value
Time frame: During the intraoperative period, assessed at 5 minutes after rigid bronchoscopy insertion
Mean heart rate measured after rigid bronchoscopy insertion while maintaining adequate depth of anesthesia
6 secondary outcomes
Incidence of intraoperative hypotension
Time frame: During the intraoperative and immediate postoperative period (from induction of anesthesia until discharge from the post-anesthesia care unit)
Use of vasopressors for treatment of hypotension
Time frame: During the intraoperative and immediate postoperative period (from induction of anesthesia until discharge from the post-anesthesia care unit)
Total dose of propofol used intraoperatively
Time frame: From induction of anesthesia until the end of the rigid bronchoscopy procedure
Time to recovery of consciousness
Time frame: From discontinuation of anesthetic infusions until achievement of MOAAS score ≥ 4 in the post-anesthesia care unit
Incidence of intraoperative awareness
Time frame: Assessed within 2-3 hours postoperatively in the post-anesthesia care unit
Type and incidence of postoperative complications
Time frame: During the post-anesthesia care unit stay (up to 2-3 hours postoperatively)
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 13 Feb 2026.
- Individual participant dataSharing planned: Yes
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 Phase 4 study testing Propofol saline and Propofol Dexmedetomidine in people with Patients Undergoing Rigid Bronchoscopy, run by Cairo 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 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: finished, as of the sponsor's last update on 13 Feb 2026. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean heart rate value (time frame: During the intraoperative period, assessed at 5 minutes after rigid bronchoscopy insertion). 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 13 Feb 2026.