use of melatonin to decrease the hemodynamic responses to laryngoscopy and intubation

Not yet recruiting

Conditions: decreasing laryngoscopy and intubation response in patients coming for general anesthesia

Registration Number: CTRI/2018/05/013835

Lead Sponsor: Sri Ramachandra University

Brief Summary: Laryngoscopy and endotracheal intubation are considered potent

noxious stimuli which provoke haemodynamic responses leading to a

marked increase in heart rate and blood pressure. These events are

especially detrimental in individuals who have limited myocardial

reserve due to coronary artery disease, cardiac dysrhythmias,

congestive heart failure, hypertension, cardiomyopathy and in the

geriatric age group. Hence, it is mandatory to take measures to

attenuate these pressor responses.

The mechanisms of these haemodynamic alterations are reflexes

due to sympathetic stimulation. During intubation of trachea, the

laryngeal and tracheal sensory receptors are stimulated which result

in the release of endogenous catecholamines resulting in tachycardia

and hypertension.

Since the invention of laryngoscopy and endotracheal intubation,

various drug regimens and techniques have been used from time to

time to attenuate these stress responses. Some of these agents

being opioids (fentanyl, alfentanil), calcium channel blockers

(verapamil, diltiazem), sympatholytics (clonidine, dexmedetomidine

and methyldopa), beta blockers (esmolol, propranolol),

benzodiazepines (midazolam, alprazolam), barbiturates, propofol,

pregabalin and peripheral vasodilators (sodium nitroprusside,

nitroglycerine).

However, each agent has its own limitations such as respiratory

depression with opioids and benzodiazepines, hypotension and

bradycardia with sympatholytics and beta blockers and so on. Hence,

there is always been a search for a ideal agent.

Melatonin (Nacetyl5methoxytryptamine) is an endogenous

sleepregulating hormone secreted by pineal gland. Exogenous

administration of melatonin facilitates sleep onset and improves the

quality of sleep. It is different from benzodiazepines and their

derivatives in that it produces natural sleep pattern and does not

lead to impairment of cognitive functions. Various researchers have

used this drug in different dose patterns as premedication in both

adults as well as children. Based on this we hypothesised that

melatonin when given before the procedure can provide

haemodynamic stability during laryngoscopy and intubation. The

primary objective is to assess the efficacy of melatonin to attenuate

the changes in blood pressure to laryngoscopy and intubation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Only ASA 1 and 2 patients coming for general anesthesia for surgeries longer than 30 minutes.

Exclusion Criteria

Diabetes Hypertension Psychiatric illness Intake of anti-psychotics, sedatives, anxiolytics drugs Sleep disorders Allergy to study drugs Anticipated difficult airway Pregnant and lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
outcome-To study the changes in blood pressure in	At 1,5,10 and 20 minutes
response to laryngoscopy and intubation	At 1,5,10 and 20 minutes

Secondary Outcome Measures

Name	Time	Method
To monitor any adverse effects during the	study period.

Trial Locations

Locations (1): A6 department of anesthesiology
🇮🇳
Chennai, TAMIL NADU, India
A6 department of anesthesiology
🇮🇳Chennai, TAMIL NADU, India
Shilpa Rajendran
Principal investigator
04423860830
shilpa5432@gmail.com