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A study to compare the Efficacy of IV Esmolol VS IV Dexmedetomidine in blocking pressor response to Laryngoscopy and Intubation in Patients undergoing Elective Major Surgeries.

Comparison of Efficacy of IV Esmolol VS IV Dexmedetomidine in Attenuation of Sympathomimetic response to Laryngoscopy and Intubation in Patients undergoing Elective Major Surgeries. A prospective, double-blind, randomized controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034181
Enrollment
56
Registered
2021-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Group A- Patients receiving Esmolol 2mg/kg IV Infusion over 10 minutes. Group B- Patients receiving Dexmedetomidine 1mcg/kg IV Infusion over 10 minutes.: The study drugs (Esmolol 2 mg/k

Sponsors

Dr Arundhati Chadha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing Elective Major surgeries, Patient related factors, 1. Adults between 30 to 65 yrs. 2. BMI between 18.5 to 30 kg per m2 . 3. Mallampati Airway class I and II. 4. ASA I, II and III patients. Surgery related factors, 1. Operative time more than 4 hours. 2. Expected Excessive intra operative blood loss. 3. Expected peri operative blood transfusion of more than or equal to 2 PRBC. 4. And, or one of the following surgeries, i. Radical hysterectomy. ii. TURP. iii. Discectomy, Laminectomy. iv. Thyroidectomy. v. lung operations. vi. Ileostomy, colectomy. vii. Neck lymph node dissection. viii. Neurosurgeries. ix. Heart surgeries.

Exclusion criteria

Exclusion criteria: 1. Unwillingness to give consent. 2. Allergy to any of the drugs. 3. Anticipated Difficult Airway. 4. Intubation attempts lasting for more than 30 secs. 5. Left ventricular ejection fraction less than 45 percent. 6. Pregnant and lactating females. 7. Acute or Chronic Renal Disease. 8. Acute or Chronic Liver Disease. 9. Chronic Obstructive Pulmonary Disease. 10. ASA IV, V and VI patients.

Design outcomes

Primary

MeasureTime frame
1. Primary Outcome measure - Heart rate, Systolic Blood pressure, Diastolic Blood Pressure, Mean arterial Pressure.Timepoint: At Baseline, At each minute of Study Drug Infusion for 10 mins, During Intubation, After Intubation, At each minute for 10 minutes, At 15 mins, 30 mins and 1 hour after intubation.—

Secondary

MeasureTime frame
Bi spectral Index (BIS %)Timepoint: Baseline, after study drug infusion/immediately after induction (SDI at 10mins), During laryngoscopy and Intubation (DI), After intubation (AI-0-10) at each minute for 10 mins, During skin incision, At 15 mins, 30 mins and 1 hour after intubation.—

Countries

India

Contacts

Public ContactArundhati Chadha

All India Institute of Medical sciences, Raipur

subratsingh@gmail.com8518881767

Outcome results

None listed

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