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 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.

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 In case of persistent hypoxemia despite adequate jet ventilation, RB will be withdrawn followed by endotracheal intubation and mechanical ventilation.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 Overview

• Status: Completed
• Conditions: Patients Undergoing Rigid Bronchoscopy
• Intervention / Treatment: Drug: Propofol saline; Drug: Propofol Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 18 - 60 years, scheduled for elective rigid bronchoscopy procedure.
• ASA physical status I-II
• Both genders.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Propofol Saline	Drug: Propofol saline; 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.; Other Names: Rigid bronchoscopy; Patient State Index monitor; manual jet ventilation; Modified Observer's Assessment of Alertness/Sedation scale; modified Brice questionnaire; face mask ventilation
Other: Propofol Dexmedetomidine	Drug: Propofol Dexmedetomidine; 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.; Other Names: Rigid bronchoscopy; Modified Observer's Assessment of Alertness/Sedation scale; modified Brice questionnaire; face mask ventilation; manuel jet ventilation; Patient State Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean heart rate value	Mean heart rate measured after rigid bronchoscopy insertion while maintaining adequate depth of anesthesia	During the intraoperative period, assessed at 5 minutes after rigid bronchoscopy insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	Hypotension defined as mean arterial blood pressure < 60 mmHg occurring during the perioperative period.	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)	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	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	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	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	During the post-anesthesia care unit stay (up to 2-3 hours postoperatively)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MD-38-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No