Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.

NCT07352059 | Not Yet Recruiting

• 1 other identifier: IRB/2025/1732/SIMS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy

Keywords

Flexible bronchoscopy, midazolam, ketorolac, sedation, analgesia, patient comfort, safety, procedural tolerance

Outcome Measures

Primary Outcomes (1)

• 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.

  During the procedure and within 30 mints after bronchoscopy.

Study Arms (2)

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.

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.

Drug: Midazolam + ketorolac

Interventions

Midazolam Alone DRUG

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 Sedation Alone for Flexible Bronchoscopy

Midazolam + ketorolac DRUG

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.

Also known as: Dormicum, Toradol

Midazolam with Ketorolac Sedation for Flexible Bronchoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years. Patients undergoing flexible bronchoscopy. ASA physical status I-III. Patients able to provide informed written consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SYED HAIDER ALI: lead

Related Publications (1)

• 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.

  PMID: 11989050 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Midazolam; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Indomethacin; Indoles

Central Study Contacts

SYED HAIDER ALI, MBBS

CONTACT

+923337240759; Dr_syedhaider@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. No parties are masked in this open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registrar

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 20, 2026
• Study Start: January 20, 2026
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share