Study to compare oral clonidine versus oral melatonin premedication on hemodynamic responce to laryngoscopy and intubation
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- to compare different effect of oral melatonin versus oral clonidine as premedication and its response changes in blood pressure , heart rate, and other relevant haemodynamic parameters during direct laryngoscopy and tracheal intubation during induction of general anesthesia in elective surgery
Study Overview
Brief Summary
Direct laryngoscopy and endotracheal intubation during general anesthesia acts as a powerful noxious stimulus which causes stimulation of sympathetic nervous system. This leads to various responses in various physiological systems of the body such as tachycardia, hypertension, arrythmia, bronchospasm, increased intracranial pressure, elevation in intraocular pressure.
Melatonin is a natural substance produced mainly in the pineal gland Its secretion is high during night and low during day.premedication with sublingual/oral Melatonin is associated with pre-operative anxiolysis and sedation without impairment of orientation, psychomotor skills, or impact on quality of recovery.
Clonidine parasympathetic activity by acting on alpha receptor present over tractus solitarius Major site of action for this sedative/hypnotic. Clonidine has various properties like sedation, anxiolysis, antisialogogue, potentiates the anesthetic action of the drugs and reduces their requirements during surgery and attenuation of stress response to noxious stimuli on tracheal intubation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient posted for elective surgery under General anesthesia Patient aged between 18-65 years Patient with American Society of anesthesiologists (ASA) Class I, II Consented Patients.
Exclusion Criteria
- •Anticipated difficult intubation Pregnant and lactating females Patient receiving treatment with either of the study drug or having known case of allergy to either drugs or any drugs Patients with prolonged laryngoscopy time(more than 30 seconds) Body Mass Index (BMI) more than 30 kg/m2.
Outcomes
Primary Outcomes
to compare different effect of oral melatonin versus oral clonidine as premedication and its response changes in blood pressure , heart rate, and other relevant haemodynamic parameters during direct laryngoscopy and tracheal intubation during induction of general anesthesia in elective surgery
Time Frame: Baseline vitals followed by vitals at 5,10,15,30,60,90 minutes pre induction vitals followed by vitals at laryngoscopy followed by vitals at 5,10,15,30 minutes.
Secondary Outcomes
- to evaluate any differences in side effects or adverse effects between two study groups(Baseline vitals and sedation score followed by vitals and sedation score at 5,10,15,30,60,90 minutes pre induction vitals followed by vitals at 5,10,15,30 minutes and postoperative vitals and sedationscoreat5,10,15,30,60 minutes.)
Investigators
Rahul Acharya
Mahatma Gandhi Medical College and Hospital