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

Balanced controlled hypotensive anaesthesia and optimizing surgical field in middle ear and FESS surgeries with intermittent doses of dexmedetomidine and labetalol- A Randomized clinical trial - BCHMFDL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/012012

Enrollment

Registered

2018-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: null- ASA I and II patients posted for elective middle ear and FESS surgeries

Interventions

Intervention1: inj dexmedetomidine: inj dexmedetomidine loading dose of 1mcg/kg over 10mins followed by intermittent doses of 1/4th the loading dose given over 2mins Intervention2: inj labetalol20mg i

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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 2. After extubation 3. PACU/ ward- 6h	—

Countries

India

Contacts

Public ContactDr Navya C N

Sri Muthukumaran Medical College Hospital and Research Institute

drcn.navya@gmail.com9791793965

Outcome results

None listed

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