Comparison of Bolus and Continuous Intravenous Infusion of Dexmedetomidine on Intraoperative Hemodynamic Stability in ENT Surgeries Under General Anesthesia

Study to compare the effect of bolus versus intravenous infusion of Dexmedetomidine on intraoperative hemodynamics in ENT surgeries under general anaesthesia. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101190

Enrollment

Registered

2026-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine given as an intravenous bolus: Drug Dexmedetomidine Dose 1 microgram per kilogram body weight Route Intravenous Method of administration Slow intravenous bolus infusi

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I or II Patients scheduled for elective ENT surgeries under general anesthesia Patients requiring endotracheal intubation Patients who have given written informed consent Expected surgical duration of 30 180 minutes

Exclusion criteria

Exclusion criteria: Patient refusal to participate ASA physical status three or four Known allergy or hypersensitivity to dexmedetomidine Baseline bradycardia with heart rate less than sixty beats per minute Hypotension with systolic blood pressure less than ninety millimeters of mercury or uncontrolled hypertension Cardiac conduction abnormalities such as heart block or sick sinus syndrome Patients on drugs affecting heart rate or blood pressure such as beta blockers calcium channel blockers digoxin or clonidine History of ischemic heart disease heart failure or significant arrhythmias Severe hepatic or renal impairment Pregnant or lactating women Emergency surgeries Anticipated difficult airway or need for rapid sequence induction Chronic alcohol or substance abuse

Design outcomes

Primary

Measure	Time frame
To evaluate and compare intraoperative hemodynamic stability, measured by mean arterial pressure and heart rate, in patients receiving dexmedetomidine as a bolus versus continuous intravenous infusion during ENT surgeries under general anesthesiaTimepoint: Hemodynamic parameters were recorded at baseline before dexmedetomidine administration (T0); at 5 and 10 minutes after bolus/start of infusion (T1, T2); just before induction (T3); immediately after induction (T4); during laryngoscopy (T5); at 1, 3, and 5 minutes after endotracheal intubation (T6 T8); at 15, 30, 45, and 60 minutes after intubation (T9 T12); at completion of surgery (T13); at extubation (T14); and 5 minutes after extubation (T15).	—

Measure

Time frame

To evaluate and compare intraoperative hemodynamic stability, measured by mean arterial pressure and heart rate, in patients receiving dexmedetomidine as a bolus versus continuous intravenous infusion during ENT surgeries under general anesthesiaTimepoint: Hemodynamic parameters were recorded at baseline before dexmedetomidine administration (T0); at 5 and 10 minutes after bolus/start of infusion (T1, T2); just before induction (T3); immediately after induction (T4); during laryngoscopy (T5); at 1, 3, and 5 minutes after endotracheal intubation (T6 T8); at 15, 30, 45, and 60 minutes after intubation (T9 T12); at completion of surgery (T13); at extubation (T14); and 5 minutes after extubation (T15).

—

Secondary

Measure	Time frame
Incidence of bradycardia and hypotension during the intraoperative period Requirement of rescue medications such as anticholinergics or vasopressors Total anesthetic and opioid requirement during surgery Quality of surgical field and degree of bleeding as assessed by the surgeon Time to emergence and extubation Postoperative sedation level Incidence of postoperative nausea vomiting and shivering Adverse effects related to dexmedetomidineTimepoint: assessment of secondary outcomes Intraoperative period throughout surgery At the end of surgery before extubation Immediately after extubation Postoperative period At fifteen minutes after extubation At thirty minutes after extubation At one hour after extubation At two hours after extubation	—

Measure

Time frame

Incidence of bradycardia and hypotension during the intraoperative period Requirement of rescue medications such as anticholinergics or vasopressors Total anesthetic and opioid requirement during surgery Quality of surgical field and degree of bleeding as assessed by the surgeon Time to emergence and extubation Postoperative sedation level Incidence of postoperative nausea vomiting and shivering Adverse effects related to dexmedetomidineTimepoint: assessment of secondary outcomes Intraoperative period throughout surgery At the end of surgery before extubation Immediately after extubation Postoperative period At fifteen minutes after extubation At thirty minutes after extubation At one hour after extubation At two hours after extubation

—

Countries

India

Contacts

Public ContactParvathareddy sri sai jaswanth

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals

sabapathyv.appavoo@gmail.com9442566989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026