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Comparison of two drugs (dexmedetomidine and midazolam)which calm down and decreases anxiety in patients undergoing medical thoracoscopy - a randomized controlled pilot study

Comparison of dexmedetomidine vs midazolam in conscious sedation for patients undergoing medical thoracoscopy- a randomized controlled pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014377
Enrollment
60
Registered
2018-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: null- Patients would be suffering from lung disease and planned for thoracoscopy

Interventions

Intervention1: Dexmedetomidine(D) group: Dexmedetomidine started at 1 microgram/kg for 10 minutes, then it will continue at rate of 0.2-0.7 microgram/kg. Control Intervention1: Midazolam(M) group: Int

Sponsors

All India Institute of Medical Sciences AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: weight between 30 and 80 kg ASA- I-III patients undergoing medical thoracoscopy under conscious sedation Informed written consent

Exclusion criteria

Exclusion criteria: a)Intubated patients b)patients with a known allergy or intolerance to midazolam, fentanyl and dexmedetomidine c)pregnant or nursing women d)patients with a mental disorder preventing appropriate judgment concerning study participation e)hypersensitivity or allergy to the study drugs f)uncontrolled hypertension (uncontrolled blood pressure >140/90 mmHg) g)major abnormalities of liver function, ischemic heart disease and severe respiratory disease

Design outcomes

Primary

MeasureTime frame
To compare the effects of dexmedetomidine and midazolam in conscious sedation for patients undergoing medical thoracoscopy on pulmonologist and patient satisfaction.Timepoint: Pulmonologist satisfaction at the end of procedure and patient satisfaction at 2 hours after the procedure will be evaluated.

Secondary

MeasureTime frame
To compare the effects of dexmedetomidine and midazolam in conscious sedation for patients undergoing medical thoracoscopy on hemodynamic variables.Timepoint: during the procedure

Countries

India

Contacts

Public ContactDr Vinod Kumar

AIIMS

vkchanpadia@gmail.com8800824061

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026