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

• Conditions: Health Condition 1: null- elective lumber spine surgery.

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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)Timepoint: 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) <br/ ><br>Baseline sedation status will be assessed by an observer using theRamsay sedation scale <br/ ><br>any other side effectTimepoint: 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. <br/ ><br>Baseline sedation status will be assessed by an observer using theRamsay sedation scale before induction