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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

Comparative Study Between Intranasal and Intravenous Dexmedetomidine As A Premedication To Attenuate Hemodynamic Response To Laryngoscopy And Endotracheal Intubation In Elective Lumbar Spine Surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012556
Enrollment
70
Registered
2018-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- elective lumber spine surgery.

Interventions

Intervention1: intranasal dexmedetomidine: intranasal dexmedetomidine at a dose of 1 mcg/kg body weight along with IV 0.9% normal saline infuse over 45 minutes before induction Control Intervention1:

Sponsors

Bangur Institute of Neurosciences
Lead Sponsor

Eligibility

Inclusion criteria

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) 5)Patients of either sex 6)Patients posted for elective lumber spine surgery under general anaesthesia

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
heart rate (HR), , respiratory rate (RR) and oxygen saturation (spO2) Baseline sedation status will be assessed by an observer using theRamsay sedation scale 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. Baseline sedation status will be assessed by an observer using theRamsay sedation scale before induction

Primary

MeasureTime frame
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.

Countries

India

Contacts

Public ContactSaikat Niyogi

IPGMER

saikatneuro1972@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026