A clinical trial to study the effects of nasal and venous dexmetomidine on change of blood pressure and heart rate during anaesthesia in lumber spine surgery

Phase 3

Recruiting

• Conditions: elective lumber spine surgery.

• Registration Number: CTRI/2018/03/012556
• Lead Sponsor: Bangur Institute of Neurosciences

Brief Summary

**1.**Laryngoscopy andtracheal intubation violate the patient’s airway reflexes and predictably leadto hypertention and tachecardia.Dexmedetomidine is a potent, highly selectiveand specific alpha2 agonist that has both sedative and analgesic effects withminimal respiratory depression. Various methods of drug delivery areoral,rectal, intravenous, intramuscular ,but intranasal route is advantageousin that it is easy to use, painless, odourless,tasteless, well tolerated,avoids first pass metabolism with more haemodynamic stability1

**2.****Methodology:**A prospective randomized doubleblind study will be carried out on 70( ASA-1andII)patients, aged 18-60years,scheduled for elective lumbar spine surgery under generalanaesthesia.Group -DIN,patients will receive intranasaldexmedetomidine1 mcg/kg andGroupDI.V  willreceive  intravenous Dexmedetomidine at0.75µg/kg before induction.Hemodynamic response  will be monitored in every 10 min intervalsfrom drug administration to induction,  immediatelyafter intubation,  then every 1 min interval till 5mins and at 7 min and 10 min afterintubation.

**3.****Expected outcome :**The primary expectedoutcome from the study that whether the effect of intranasal Dexmedetomidine is superior,equivalent orinferior to that of intravenous Dexmedetomidine during laryngoscopy andintubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-07
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1)Patients with ASA physical status I and II.
• 2)Patients having Mallampati I and II 3)Patients in the age group between 18 to 60 years of age 4)Patients with body mass index (BMI) < 30 kg/m2 5)Patients of either sex 6)Patients posted for elective lumber spine surgery under general anaesthesia.

Exclusion Criteria

• 1)Patients refusal to participate in the study 2)Known allergy or hypersensitive reaction to dexmedetommidine.
• 3)Patients suffering from significant cardiac disease e.g. IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc.
• 4)Patients suffering from significant respiratory disease e.g. COPD, bronchial asthma, interstitial lung diseases, pneumonia etc.
• •Patients having metabolic, endocrinal, musculoskeletal, neurologic disorder or having major congenital anomalies.
• •History of drug abuse and/or psychiatric disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure (MAP)	Mean arterial pressure (MAP) at baseline then every 10 min intervals from intranasal dexmedetomidine administration in preinduction period, during induction, after intubation, every 1 min interval till 5mins and at 7 min and 10 min after intubation.

Secondary Outcome Measures

Name	Time	Method
heart rate (HR), , respiratory rate (RR) and oxygen saturation (spO2)	Baseline sedation status will be assessed by an observer using theRamsay sedation scale

Trial Locations

Locations (1)

Bangur Institute of Neurosciences,Anaesthesia department; 🇮🇳 Kolkata, WEST BENGAL, India

Bangur Institute of Neurosciences,Anaesthesia department

🇮🇳Kolkata, WEST BENGAL, India

SAIKAT NIYOGI

Principal investigator

9831732443

saikatneuro1972@gmail.com