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

Completed

• Conditions: Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/06/034181
• Lead Sponsor: Dr Arundhati Chadha

Brief Summary

Laryngoscopy and endotracheal intubation during general anesthesia causes significant hemodynamic disturbance due to stimulation of the sympathoadrenal system. For patients undergoing Major surgeries, tachycardia and hypertension due to the stress of laryngoscopy and intubation increases the risk of perioperative myocardial ischemia and infarction.

Esmolol is an ultra-short acting beta-adrenergic receptor antagonist which minimizes the increase in HR and myocardial contractility by attenuating the positive chronotropic and inotropic effects of increased adrenergic activity, without significant adverse effects.

Dexmedetomidine is an imidazole derivative and highly selective alpha2-adrenergic receptor agonist, which also decreases HR and Bood pressure with additional dose-dependent sedation, anxiolysis and analgesia due to its effect on the central adrenergic outflow.

Also, the effects of laryngoscopy and intubation on changes in the bi spectral index (BIS) are unclear.

We by means of this study, aim to compare the efficacy of these two drugs in attenuating this pressor response, even though short lived, to laryngoscopy and intubation, which may otherwise prove detrimental to patients in these patients. And to also note the effect of laryngoscopy and intubation on BIS and see whether or not the drugs used to suppress pressor response have any effect on BIS variations, if any, too.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Study Completion: 2021-12-27
• Last Update Posted: 2022-10-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients undergoing Elective Major surgeries, Patient related factors, 1.
• Adults between 30 to 65 yrs.
• BMI between 18.5 to 30 kg per m2 .
• Mallampati Airway class I and II.
• ASA I, II and III patients.
• Surgery related factors, 1.
• Expected Excessive intra operative blood loss.
• Expected peri operative blood transfusion of more than or equal to 2 PRBC.
• And, or one of the following surgeries, i.
• Radical hysterectomy.
• Discectomy, Laminectomy.
• Thyroidectomy.
• lung operations.
• Ileostomy, colectomy.
• Neck lymph node dissection.
• Neurosurgeries.
• Heart surgeries.

Exclusion Criteria

• Unwillingness to give consent.
• Allergy to any of the drugs.
• Anticipated Difficult Airway.
• Intubation attempts lasting for more than 30 secs.
• Left ventricular ejection fraction less than 45 percent.
• Pregnant and lactating females.
• Acute or Chronic Renal Disease.
• Acute or Chronic Liver Disease.
• Chronic Obstructive Pulmonary Disease.
• ASA IV, V and VI patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary Outcome measure - Heart rate, Systolic Blood pressure,	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.
Diastolic Blood Pressure, Mean arterial Pressure.	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 Outcome Measures

Name	Time	Method
Bi spectral Index (BIS %)	Baseline,

Trial Locations

Locations (1)

AIIMS, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

AIIMS, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Arundhati Chadha

Principal investigator

8178937529

arundhatichadha@gmail.com