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.
Age≥18 and ≤80 years
Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion
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
Parallel
Dexmedetomidine
DrugThe 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
Midazolam
DrugThe 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.
Total amount of rescue medication (sedation or analgesia) required during MT.
The total amount of rescue medication bolus will be counted
Pulmonologist rated ease of the procedure (satisfaction visual analogue scale [VAS])
Operator rated ease of procedure will be analysed using VAS (0 mm being very easy; 100 being most difficult)
Pulmonologist rated incidence of cough on 100 mm VAS (cough VAS);
Operator s assessment of cough during procedure will be assessed using VAS
Patient rated VAS 2 hours after completion of the procedure
Patients comfort during procedure will be assessed after procedure using VAS (0 mm being very comfortable; 100 mm being very uncomfortable)
Willingness to undergo repeat thoracoscopy if required
Patient's willingness to undergo procedure will be assessed using visual analogue scale (0 mm being least willing; 100 being most willing)
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