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Clinical Trials/CTRI/2024/08/072395
CTRI/2024/08/072395Not yet recruitingPhase 3

Effects of adding Dexmedetomidine to 4 Percent Lignocaine nebulization on hemodynamic stress response to laryngoscopy and intubation : A Randomized Control Trial

Dr Lakesh K Anand1 site in 1 country80 target enrollmentStarted: August 26, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
To evaluate the effects on the Heart rate and Blood pressure (SBP, DBP and MAP) in adult patients.

Study Overview

Brief Summary

Laryngoscopy and endotracheal intubation often trigger significant hemodynamic responses (HDR), such as increased heart rate and blood pressure, lasting at least 10 minutes. These responses are due to sympathoadrenal activation from stretching pharyngeal and laryngeal tissues. While manageable in healthy individuals, HDR can be risky for those with compromised cardiac function. Various anesthetic techniques and medications aim to mitigate these responses.Dexmedetomidine, an alpha-2 adrenoceptor agonist, helps manage haemodynamic response by providing sedation, analgesia, and reducing sympathetic activity, which lowers heart rate and blood pressure. Dexmedetomidine selectively binds to alpha-2A receptors, which affects all three types of alpha-2 receptors. This binding inhibits adenyl cyclase, lowering adenosine monophosphate levels and causing hyperpolarization of noradrenergic neurons. As a result, nerve conduction is suppressed by blocking calcium entry needed for neurotransmitter release, leading to reduced sympathetic activity, lower heart rate, and blood pressure . It can be administered intravenously, intramuscularly, intranasally, buccally, or via nebulization. Lignocaine, a local anesthetic, is used to numb tissues and manage cough during procedures like bronchoscopy and laryngoscopy. Lignocaine is used to manage cough in various clinical scenarios. It has been tested as a spray or gel to suppress acute cough during procedures like bronchoscopy and laryngoscopy. It also helps alleviate postoperative sore throat, cough, and hoarseness, and can be administered via nebulizer for severe cough in terminal patients. As an amide local anesthetic, lignocaine reduces hemodynamic responses to tracheal intubation by acting as a myocardial depressant and having central stimulant effects. Hence the purpose of this study is  to compare the effectiveness of using dexmedetomidine and lignocaine nebulization  together versus each drug alone in attenuating the haemodynamic stress responses to laryngoscopy and endotracheal intubation .

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • either gender of age 18-40 ears and ASA I and ASA II status patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia.

Exclusion Criteria

  • Patients with increased risk of regurgitation and aspiration of gastric Contents.
  • Patients with Difficult airway.
  • Patients with upper respiratory tract infections Patients with hepatic or renal insufficiency Patients with history of smoking or exposure to household smoke.
  • Patients with Cardiac diseases Pregnant patients Patients with known allergy to study drug.

Outcomes

Primary Outcomes

To evaluate the effects on the Heart rate and Blood pressure (SBP, DBP and MAP) in adult patients.

Time Frame: 5 minutes before nebulization, immediately intubation, 1minute after intubation,5 minutes after intubation, 30 minutes after extubation

Secondary Outcomes

  • To evaluate the postoperative sore throat & pain.(Before nebulization, after intubation, after extubation)

Investigators

Sponsor
Dr Lakesh K Anand
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Lata Devi

Maharishi Markendeshwar institute of medical sciences and research , Mullana

Study Sites (1)

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