Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy

NCT07184801 | Recruiting Phase 3 DMC

• 1 other identifier: IEC-INT/2025/DM-2480
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Medical thoracoscopy can be performed under procedural sedation (conscious sedation) in most of the cases. Procedural sedation is a state where the patient lies comfortably without much movement, does not feel pain and has a dissociative state (separation of mind and body. In view of the existing literature, we hypothesize that use of dexmedetomidine for procedural sedation during medical thoracoscopy will improve the ease of performing the procedure, lower the consumption of rescue analgesics and risk of intra- and post-procedure complications, improve the yield, shorten the recovery period and reduce the post-procedure pain in comparison to midazolam. In this study we propose to show that procedural sedation with dexmedetomidine during medical thoracoscopy is more beneficial for both patient and the clinician in terms of yield and shorter procedure time in comparison with conventional midazolam-fentanyl combination.

Conditions

Medical Thoracoscopy

Keywords

Thoracoscopy, Midazolam, sedation

Outcome Measures

Primary Outcomes (1)

• Total amount of rescue medication (sedation or analgesia) required during MT.

  The total amount of rescue medication bolus will be counted

  6 hours

Secondary Outcomes (7)

• Pulmonologist rated ease of the procedure (satisfaction visual analogue scale [VAS])

  6 hours

• Pulmonologist rated incidence of cough on 100 mm VAS (cough VAS);

  6 hours

• Patient rated VAS 2 hours after completion of the procedure

  6 hours

• Willingness to undergo repeat thoracoscopy if required

  6 hours

• Adverse events

  6 hours

Study Arms (2)

Group 1

EXPERIMENTAL

Immediately before procedure * 2 mL normal saline bolus * 1 µg /Kg fentanyl in 0.9% normal saline (10 mL dose volume) IV as slow bolus * Dexmedetomidine 1 µg /Kg in 0.9% normal saline (100 mL) over 10 minutes During entire procedure • Dexmedetomidine (30 mcg in 0.9% saline, 50 ml) infused at a rate of 0.5 µg /Kg/hour Rescue boluses * 0.5 µg /Kg of Fentanyl IV boluses up to 100 µg total. * If further need of analgesia despite 100 µg of Fentanyl, Injection Tramadol 50 mg IV bolus as needed upto 200 mg total dose.

Drug: Dexmedetomidine

Group 2

ACTIVE COMPARATOR

Immediately before procedure * 2 mg midazolam * 1 µg /Kg Fentanyl, in 0.9% saline IV slow bolus * 100 mL 0.9% normal saline (100 mL) over 10 minutes During entire procedure * 0.9% normal saline 50 mL infused at a rate of 0.5 µg /Kg/Hr Rescue boluses * 0.5 µg /Kg of Fentanyl IV boluses up to 100 µg total. * If further need of analgesia despite 100 µg of Fentanyl, Injection Tramadol 50 mg IV bolus as needed upto 200 mg total dose.

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

The patient will receive dexmedetomidine bolus dose of 1 µg /Kg over 10 minutes followed by 0.5 µg /kg/hr infusion titrated to desired sedation level (RSS 3). For patients who do not achieve an RSS of 3, we will give 1 mg bolus of midazolam. All additional boluses will be recorded. The patient will initially receive a bolus of 2 mL 0.9% normal saline intravenously for blinding purpose

Also known as: Dexmed

Group 1

Midazolam DRUG

The patient will receive midazolam bolus dose of 2 mg IV. They will receive an infusion of normal saline over 10 minutes for blinding purpose. Further need of sedation (as assessed by RSS) will be met by additional IV boluses of 1 mg midazolam. During the procedure they will receive continuous infusion of normal saline at a rate of 0.5 µg /Kg/Hr as placebo.

Also known as: Midas

Group 2

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 and ≤80 years
• Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion

You may not qualify if:

• Patients with ICD in situ for more than 5 days
• SP02\<92%
• Haemodynamic instability (systolic blood pressure ≤90 mmHg or \>180mmHg, or diastolic BP \>110mmHg) before the procedure
• MI/unstable angina in the last 3 months
• Hb\<8g/dL, platelet\<50000 cells/dL
• Lack of pleural space due to adhesion
• Uncorrected coagulopathy (PT\>3 secs above control; APTT\>10 secs above control
• Failure to provide informed consent
• Patients with known allergy or previously recorded severe adverse events to the sedatives used in the study
• Patients who required any anaesthetic/analgesic agent in past 7 days
• Patients on psychotropic drugs that may alter sensorium

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Bronchoscopy suite

Chandigarh, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; GOLPH3 protein, human

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Inderpaul S Sehgal, DM

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inderpaul S Sehgal, DM

CONTACT

+91-1722756820; inderpgi@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: To compare the efficacy and safety of Dexmedetomidine vs Midazolam for conscious sedation among patients undergoing medical thoracoscopy

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IN (1)