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Decreasing blood loss and providing better surgical field in middle ear and FESS surgeries

Phase 4
Completed
Conditions
Health Condition 1: null- ASA I and II patients posted for elective middle ear and FESS surgeries
Registration Number
CTRI/2018/02/012012
Lead Sponsor
Sri muthukumaran medical colle hospital and research institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.ASA I or II (no or minimal co-morbid disease)

2.Patients scheduled for elective middle ear and FESS surgeries

Exclusion Criteria

1.ASA > III

2.History of allergy or contraindications to either Dexmedetomidine or labetalol

3.Concomitant use of medications which may exaggerate the heart rate response of Dexmedetomidine including digoxin or ß-adrenergic antagonists.

4.Coronary artery disease,

5.ischemic heart disease,

6.hypertension,

7.rhythm disturbances,

8.Bronchial asthma,

9.diabetes mellitus

10.history of sleep apnea,

11.renal insufficiency,

12.cerebral insufficiency,

13.liver impairment,

14.bleeding disorders,patients on medications affecting coagulation system

15.administered medication for psychiatric diseases,

16.chronic or acute intake of sedative or analgesic drugs, and patient refusal.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary objective: to evaluate and compare the effectiveness of dexmedetomidine and labetalol in inducing deliberate hypotension and providing better quality of the surgical field during middle ear and FESS surgeries under general anesthesiaTimepoint: NIBP, HR recorded before and 2 min after administration of drug,1min after induction and at 1, 3, 5 and 10, min after intubation, then every 15min till the end of surgery.
Secondary Outcome Measures
NameTimeMethod
Effect on amount of blood loss, hemodynamic changes, postoperative recovery, discharge, shivering, satisfaction of the surgeons, recovery profile, adverse effects and postoperative need for analgesia.Timepoint: 1. every 15 min during surgery <br/ ><br>2. After extubation <br/ ><br>3. PACU/ ward- 6h
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