Sedation and Analgesia Management in Patients Undergoing Flexible BronchoscopyNCT07352059
Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.
A study testing Midazolam Alone and Midazolam + ketorolac in people with Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy, run by SYED HAIDER ALI.
Trial summary
Flexible bronchoscopy has evolved into a vital diagnostic and therapeutic intervention in respiratory medicine due to its frequent and diverse applications. It enables direct visualization of the tracheobronchial tree and facilitates procedures such as bronchoalveolar lavage, tissue sampling, and foreign body… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy
- What is being tested?
- Midazolam Alone and Midazolam + ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years. Patients undergoing flexible bronchoscopy. ASA physical status I-III. Patients able to provide informed written consent.
- -
Who cannot join
- History of bronchial asthma or NSAID-exacerbated respiratory disease (NERD). Known hypersensitivity or contraindication to midazolam or NSAIDs (e.g., ketorolac).
- Coagulopathy or platelet count < 70,000/µL. Active peptic ulcer disease or diagnosed bleeding disorder. Severe renal impairment CKD grade 3 or 4 with eGFR <50ml/min or hepatic failure.
- Chronic opioid use or benzodiazepine dependency. Unstable cardiorespiratory status (e.g., respiratory failure or requiring high-flow oxygen).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Midazolam Alone Versus Midazolam With Ketorolac in Patients Undergoing Flexible Bronchoscopy.
Flexible bronchoscopy has evolved into a vital diagnostic and therapeutic intervention in respiratory medicine due to its frequent and diverse applications. It enables direct visualization of the tracheobronchial tree and facilitates procedures such as bronchoalveolar lavage, tissue sampling, and foreign body extraction. However, despite its clinical importance, the procedure is associated with patient discomfort due to airway manipulation, hypoxia, coughing and procedural pain. These discomforts can lead to poor patient cooperation, excessive movement, procedure related anxiety and even premature termination of the procedure, consequently affecting diagnostic accuracy and patient safety.
Multiple technique has been used should be improved procedural tolerance and adequate sedation is of the prime importance. Sedation during bronchoscopy helps in reducing anxiety, suppressing the cough reflex, minimizing procedural duration and reduce overall complications. An ideal sedative agent should allow quick procedural recovery, ensuring patient comfort, procedural safety and overall diagnostic yield.
Read more
Sedative agents have dose dependent side effects including bradycardia, hypotension, respiratory depression, hypoxia which may lead to termination of procedure. Higher doses of topical analgesia with lignocaine can lead to seizures and bradycardia.
Multiple studies elaborate that addition of analgesia with some dose of sedation can improve patient tolerance and hence safety without additional side effects. Similar findings have reported in gastroenterology and surgery units, where moderate sedation with analgesia not only improved the patient comfort and procedural cooperation but also reduced the peri-procedural anxiety, better patient satisfaction and decreased risk of procedure interruption.
Ketorolac tromethamine (Toradol) is a highly effective nonsteroidal anti-inflammatory drug (NSAID) with potent analgesic action without inducing respiratory depression. When administered intravenously prior to bronchoscopy, ketorolac may reduce pain, improve comfort, and maintain cardiovascular stability. It has a rapid onset and is generally safe to combine with sedatives such as midazolam. To ensure patient safety, individuals with known contraindications to NSAIDs, including bronchial asthma, are excluded from the present study.
This study therefore aims to compare the effects of midazolam alone versus midazolam combined with ketorolac on patient comfort, sedation quality, and safety during flexible bronchoscopy. The results may assist in designing a more effective and patient-friendly sedation strategy for bronchoscopy in Pakistan.
Read the detailed description
Flexible bronchoscopy has emerged as a cornerstone in the evaluation and management of respiratory diseases, providing clinicians with the ability to directly visualize the tracheobronchial tree and perform a wide array of diagnostic and therapeutic procedures. Its applications include bronchoalveolar lavage for cytological and microbiological analysis, endobronchial tissue biopsy for histopathological assessment, and removal of foreign bodies or secretions obstructing the airway. Despite its widespread use and clinical importance, flexible bronchoscopy remains a procedure that can cause significant discomfort and anxiety for patients. The manipulation of the airway often triggers coughing, dyspnea, hypoxia, and pain, which may lead to excessive movement, impaired cooperation, and in some cases, premature termination of the procedure. These challenges can compromise both patient safety and the accuracy of diagnostic outcomes.
To mitigate these issues, sedation and analgesia are routinely employed to improve procedural tolerance. Effective sedation reduces anxiety, suppresses involuntary airway reflexes, and shortens procedure duration, all while maintaining patient safety. The ideal sedative agent for bronchoscopy should achieve a balance between adequate sedation and rapid recovery, allowing for procedural efficiency, patient comfort, and optimal diagnostic yield. However, the use of sedative agents is not without risk. Dose-dependent complications, such as bradycardia, hypotension, respiratory depression, and hypoxia, may occur and can necessitate interruption or termination of the procedure. Furthermore, the use of topical anesthetics like lignocaine at higher doses carries the potential for serious adverse effects including seizures and cardiac arrhythmias.
Research in both pulmonary medicine and other procedural disciplines, such as gastroenterology and surgery, has demonstrated that combining analgesics with sedative agents can enhance patient comfort and procedural cooperation while minimizing complications. Moderate sedation combined with analgesia has been associated with reduced peri-procedural anxiety, improved patient satisfaction, decreased risk of procedural interruption, and overall better procedural outcomes. This approach leverages the synergistic effects of sedatives and analgesics to provide a safer and more tolerable procedural experience.
Ketorolac tromethamine (Toradol) is a potent nonsteroidal anti-inflammatory drug with strong analgesic properties that does not induce respiratory depression, making it an attractive option for procedural analgesia. Intravenous administration of ketorolac prior to bronchoscopy has been shown to improve patient comfort, reduce pain, and maintain cardiovascular stability. Its rapid onset and favorable safety profile allow for safe co-administration with sedative agents such as midazolam. To ensure patient safety, individuals with contraindications to NSAIDs, including those with bronchial asthma, are excluded from this study.
The primary objective of this study is to evaluate and compare the effects of midazolam alone versus midazolam combined with ketorolac on patient comfort, sedation quality, and safety during flexible bronchoscopy. Secondary objectives include assessing procedural tolerance, incidence of adverse events, hemodynamic stability, and overall patient satisfaction. By systematically investigating the benefits of combining analgesia with sedation, this study aims to inform the development of evidence-based sedation protocols that optimize patient comfort, safety, and procedural efficiency.
The findings from this research have the potential to impact clinical practice significantly, particularly in resource-limited settings like Pakistan, where optimizing procedural sedation strategies can enhance patient experience, improve diagnostic accuracy, and minimize procedural complications. This study addresses a critical gap in the literature regarding the synergistic use of sedatives and analgesics during bronchoscopy and may provide guidance for safe and effective sedation practices that can be widely adopted in clinical respiratory medicine.
- Being tested
- Midazolam Alone, Midazolam + ketorolac
- Keywords
- Flexible bronchoscopy, midazolam, ketorolac, sedation, analgesia, patient comfort, safety, procedural tolerance
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam AloneDrug
Intravenous midazolam 0.05 mg/kg (maximum 5 mg), administered in divided doses 2.5mg bolus followed by 1.5mg and 1mg bolus if required. Each midazolam dose will be followed by saline bolus of 10 ml to facilitate rapid drug delivery.
Midazolam + ketorolacDrug
Also called Dormicum, Toradol
Intravenous ketorolac 30 mg, will be administered 10-15 minutes before bronchoscopy. Intravenous midazolam 0.05 mg/kg (maximum 5 mg) administered in divided doses 2.5mg bolus followed by 1.5mg and 1mg bolus if required.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam Sedation Alone for Flexible Bronchoscopy | Active comparator | Participants receive intravenous midazolam alone for procedural sedation during flexible bronchoscopy. Safety and efficacy outcomes will be measured. Receives: Drug: Midazolam Alone |
| Midazolam with Ketorolac Sedation for Flexible Bronchoscopy | Active comparator | Participants receive intravenous midazolam combined with ketorolac for procedural sedation during flexible bronchoscopy. Safety and efficacy outcomes will be measured. Receives: Drug: Midazolam + ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sedation-related adverse events.
Sedation-related adverse events including hypoxia, hypotension, bradycardia, need for airway intervention, or premature termination of procedure will be recorded and compared between groups.
Measured: During the procedure and within 30 mints after bronchoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedation and Analgesia Management in Patients Undergoing Flexible BronchoscopyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled study comparing midazolam alone versus midazolam with ketorolac for sedation during flexible bronchoscopy. Adult patients will be assigned to one of the two groups. Primary outcomes: sedation quality, patient comfort, and procedure-related adverse events. Secondary outcomes: hemodynamic stability and recovery time. All drugs are approved and used in standard clinical practice. No investigational drugs are involved.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SYED HAIDER ALI
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, SYED HAIDER ALI, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352059
- Sponsor's protocol ID
- IRB/2025/1732/SIMS
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang CP, Cherng CH, Wong CS, Ho ST. Effects of intravenous ketorolac and fentanyl combined with midazolam on analgesia and side effects during extracorporeal shock wave lithotripsy. Acta Anaesthesiol Sin. 2002 Mar;40(1):9-12.
PubMed 11989050
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Midazolam Alone Versus Midazolam With Ketorolac in Patients Undergoing Flexible Bronchoscopy.
- ClinicalTrials.gov ID
- NCT07352059
- Acronym / sponsor ID
- IRB/2025/1732/SIMS
- Keywords
- Flexible bronchoscopy, midazolam, ketorolac, sedation, analgesia, patient comfort, safety, procedural tolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SYED HAIDER ALIOther government
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 Jan 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.
Flexible bronchoscopy has evolved into a vital diagnostic and therapeutic intervention in respiratory medicine due to its frequent and diverse applications. It enables direct visualization of the tracheobronchial tree and facilitates procedures such as bronchoalveolar lavage, tissue sampling, and foreign body extraction. However, despite its clinical importance, the procedure is associated with patient discomfort due to airway manipulation, hypoxia, coughing and procedural pain. These discomforts can lead to poor patient cooperation, excessive movement, procedure related anxiety and even premature termination of the procedure, consequently affecting diagnostic accuracy and patient safety.
Multiple technique has been used should be improved procedural tolerance and adequate sedation is of the prime importance. Sedation during bronchoscopy helps in reducing anxiety, suppressing the cough reflex, minimizing procedural duration and reduce overall complications. An ideal sedative agent should allow quick procedural recovery, ensuring patient comfort, procedural safety and overall diagnostic yield.
Sedative agents have dose dependent side effects including bradycardia, hypotension, respiratory depression, hypoxia which may lead to termination of procedure. Higher doses of topical analgesia with lignocaine can lead to seizures and bradycardia.
Multiple studies elaborate that addition of analgesia with some dose of sedation can improve patient tolerance and hence safety without additional side effects. Similar findings have reported in gastroenterology and surgery units, where moderate sedation with analgesia not only improved the patient comfort and procedural cooperation but also reduced the peri-procedural anxiety, better patient satisfaction and decreased risk of procedure interruption.
Ketorolac tromethamine (Toradol) is a highly effective nonsteroidal anti-inflammatory drug (NSAID) with potent analgesic action without inducing respiratory depression. When administered intravenously prior to bronchoscopy, ketorolac may reduce pain, improve comfort, and maintain cardiovascular stability. It has a rapid onset and is generally safe to combine with sedatives such as midazolam. To ensure patient safety, individuals with known contraindications to NSAIDs, including bronchial asthma, are excluded from the present study.
This study therefore aims to compare the effects of midazolam alone versus midazolam combined with ketorolac on patient comfort, sedation quality, and safety during flexible bronchoscopy. The results may assist in designing a more effective and patient-friendly sedation strategy for bronchoscopy in Pakistan.
Detailed description
Flexible bronchoscopy has emerged as a cornerstone in the evaluation and management of respiratory diseases, providing clinicians with the ability to directly visualize the tracheobronchial tree and perform a wide array of diagnostic and therapeutic procedures. Its applications include bronchoalveolar lavage for cytological and microbiological analysis, endobronchial tissue biopsy for histopathological assessment, and removal of foreign bodies or secretions obstructing the airway. Despite its widespread use and clinical importance, flexible bronchoscopy remains a procedure that can cause significant discomfort and anxiety for patients. The manipulation of the airway often triggers coughing, dyspnea, hypoxia, and pain, which may lead to excessive movement, impaired cooperation, and in some cases, premature termination of the procedure. These challenges can compromise both patient safety and the accuracy of diagnostic outcomes.
To mitigate these issues, sedation and analgesia are routinely employed to improve procedural tolerance. Effective sedation reduces anxiety, suppresses involuntary airway reflexes, and shortens procedure duration, all while maintaining patient safety. The ideal sedative agent for bronchoscopy should achieve a balance between adequate sedation and rapid recovery, allowing for procedural efficiency, patient comfort, and optimal diagnostic yield. However, the use of sedative agents is not without risk. Dose-dependent complications, such as bradycardia, hypotension, respiratory depression, and hypoxia, may occur and can necessitate interruption or termination of the procedure. Furthermore, the use of topical anesthetics like lignocaine at higher doses carries the potential for serious adverse effects including seizures and cardiac arrhythmias.
Research in both pulmonary medicine and other procedural disciplines, such as gastroenterology and surgery, has demonstrated that combining analgesics with sedative agents can enhance patient comfort and procedural cooperation while minimizing complications. Moderate sedation combined with analgesia has been associated with reduced peri-procedural anxiety, improved patient satisfaction, decreased risk of procedural interruption, and overall better procedural outcomes. This approach leverages the synergistic effects of sedatives and analgesics to provide a safer and more tolerable procedural experience.
Ketorolac tromethamine (Toradol) is a potent nonsteroidal anti-inflammatory drug with strong analgesic properties that does not induce respiratory depression, making it an attractive option for procedural analgesia. Intravenous administration of ketorolac prior to bronchoscopy has been shown to improve patient comfort, reduce pain, and maintain cardiovascular stability. Its rapid onset and favorable safety profile allow for safe co-administration with sedative agents such as midazolam. To ensure patient safety, individuals with contraindications to NSAIDs, including those with bronchial asthma, are excluded from this study.
The primary objective of this study is to evaluate and compare the effects of midazolam alone versus midazolam combined with ketorolac on patient comfort, sedation quality, and safety during flexible bronchoscopy. Secondary objectives include assessing procedural tolerance, incidence of adverse events, hemodynamic stability, and overall patient satisfaction. By systematically investigating the benefits of combining analgesia with sedation, this study aims to inform the development of evidence-based sedation protocols that optimize patient comfort, safety, and procedural efficiency.
The findings from this research have the potential to impact clinical practice significantly, particularly in resource-limited settings like Pakistan, where optimizing procedural sedation strategies can enhance patient experience, improve diagnostic accuracy, and minimize procedural complications. This study addresses a critical gap in the literature regarding the synergistic use of sedatives and analgesics during bronchoscopy and may provide guidance for safe and effective sedation practices that can be widely adopted in clinical respiratory medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled study comparing midazolam alone versus midazolam with ketorolac for sedation during flexible bronchoscopy. Adult patients will be assigned to one of the two groups. Primary outcomes: sedation quality, patient comfort, and procedure-related adverse events. Secondary outcomes: hemodynamic stability and recovery time. All drugs are approved and used in standard clinical practice. No investigational drugs are involved.
| Arm | Type | Receives |
|---|---|---|
| Midazolam Sedation Alone for Flexible Bronchoscopy | Active comparator | Drug: Midazolam AloneParticipants receive intravenous midazolam alone for procedural sedation during flexible bronchoscopy. Safety and efficacy outcomes will be measured. |
| Midazolam with Ketorolac Sedation for Flexible Bronchoscopy | Active comparator | Drug: Midazolam + ketorolacParticipants receive intravenous midazolam combined with ketorolac for procedural sedation during flexible bronchoscopy. Safety and efficacy outcomes will be measured. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-75 years. Patients undergoing flexible bronchoscopy. ASA physical status I-III. Patients able to provide informed written consent.
- -
Key exclusion criteria (3 listed)
- History of bronchial asthma or NSAID-exacerbated respiratory disease (NERD). Known hypersensitivity or contraindication to midazolam or NSAIDs (e.g., ketorolac).
- Coagulopathy or platelet count < 70,000/µL. Active peptic ulcer disease or diagnosed bleeding disorder. Severe renal impairment CKD grade 3 or 4 with eGFR <50ml/min or hepatic failure.
- Chronic opioid use or benzodiazepine dependency. Unstable cardiorespiratory status (e.g., respiratory failure or requiring high-flow oxygen).
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 |
|---|---|---|
| Midazolam AloneIntravenous midazolam 0.05 mg/kg (maximum 5 mg), administered in divided doses 2.5mg bolus followed by 1.5mg and 1mg bolus if required. Each midazolam dose will be followed by saline bolus of 10 ml to facilitate rapid drug delivery. | Drug | Midazolam Sedation Alone for Flexible Bronchoscopy |
| Midazolam + ketorolacAlso: Dormicum, ToradolIntravenous ketorolac 30 mg, will be administered 10-15 minutes before bronchoscopy. Intravenous midazolam 0.05 mg/kg (maximum 5 mg) administered in divided doses 2.5mg bolus followed by 1.5mg and 1mg bolus if required. | Drug | Midazolam with Ketorolac Sedation for Flexible Bronchoscopy |
Primary outcome
Incidence of sedation-related adverse events.
Time frame: During the procedure and within 30 mints after bronchoscopy.
Sedation-related adverse events including hypoxia, hypotension, bradycardia, need for airway intervention, or premature termination of procedure will be recorded and compared between groups.
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 20 Jan 2026.
- Background: PubMed 11989050Yang CP, Cherng CH, Wong CS, Ho ST. Effects of intravenous ketorolac and fentanyl combined with midazolam on analgesia and side effects during extracorporeal shock wave lithotripsy. Acta Anaesthesiol Sin. 2002 Mar;40(1):9-12.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam Alone and Midazolam + ketorolac in people with Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy, run by SYED HAIDER ALI.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 SYED HAIDER ALI, MBBS (+923337240759 ext. +923194204435, Dr_syedhaider@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sedation-related adverse events. (time frame: During the procedure and within 30 mints after bronchoscopy.). 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 NCT07352059, which also lists 1 linked publication.
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 20 Jan 2026.