Study comparing two doses of a commonly used anaesthesia drug (Dexmedetomidine) to control bleeding during sinus surgery.

A Comparative Study of Two Different Doses of Dexmedetomidine for Hypotensive Anaesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery - NILL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094201

Enrollment

Registered

2025-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: J32- Chronic sinusitis Health Condition 2: J33- Nasal polyp Health Condition 3: J34- Other and unspecified disorders ofnose and nasal sinuses

Interventions

Intervention1: Dexmedetomidine: Group A - Intravenous dexmedetomidine 0.25 microgram per kilogram body weight, administered as a bolus infusion over 30 minutes after induction of general anaesthesia.

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years undergoing elective FESS under general anaesthesia. American Society of Anesthesiologists (ASA) Class I and II (patients with no comorbidities or well-controlled comorbidities).

Exclusion criteria

Exclusion criteria: ASA Class III and above. Patients aged less than 18 years or more than 65 years. Patients with severe cardiac dysfunction or conduction blocks. Patients allergic to study drugs. Patients with coagulopathies or uncontrolled hypertension. Patients unwilling to participate in the study. Patients with cognitive or psychiatric disturbances. Patients requiring postoperative ventilation. Duration of Surgery longer than 2.5 hours

Design outcomes

Primary

Measure	Time frame
To compare the proportion of 5-minute non-invasive blood pressure (NIBP) readings achieving the target mean arterial pressure (MAP) during surgery (from induction to extubation) between the two dexmedetomidine groups (0.25 mcg/kg vs. 0.5 mcg/kg).Timepoint: Assessed intraoperatively, from induction of anaesthesia until extubation, with MAP recorded every 5 minutes.	—

Secondary

Measure	Time frame
Postoperative sedation measured using the Ramsay Sedation Score every 15 minutes for the first hour post-extubation. The mean score per patient is compared between groups.Timepoint: Assessed at 15, 30, 45, & 60 minutes after extubation in the recovery room.;To evaluate the incidence of intraoperative adverse effects (hypotension, defined as a single 5-minute NIBP reading with MAP less than 55 mmHg, or bradycardia, HR less than 60 per min) as a safety measure.Timepoint: Assessed intraoperatively, from induction of anaesthesia until extubation.	—

Measure

Time frame

Postoperative sedation measured using the Ramsay Sedation Score every 15 minutes for the first hour post-extubation. The mean score per patient is compared between groups.Timepoint: Assessed at 15, 30, 45, & 60 minutes after extubation in the recovery room.;To evaluate the incidence of intraoperative adverse effects (hypotension, defined as a single 5-minute NIBP reading with MAP less than 55 mmHg, or bradycardia, HR less than 60 per min) as a safety measure.Timepoint: Assessed intraoperatively, from induction of anaesthesia until extubation.

—

Countries

India

Contacts

Public ContactKaushik M

Naruvi Hospitals

drramyadeepika@gmail.com7898971326

Outcome results

None listed

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