A clinical trial to evaluate the effect preoperative intranasal Dexmedetomidine to decrease hypertensive response of laryngoscopy and endotracheal intubation in elective lumber spine surgery.

A randomized, double blinded, placebo controlled clinical trial to evaluate the efficacy of intranasal Dexmedetomidine as premedicant to attenuate haemodynamic response of laryngoscopy and intubation in elective lumber spine surgery.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007384

Enrollment

Registered

2016-10-20

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- 1. Preoperative anxiety and preoperative sedation. 2. Hemodynamic response to laryngoscopic surge and endotracheal intubation

Interventions

Intervention1: not applicable: not applicable Control Intervention1: Dexmedetomidine, Diazepam: Intranasal Dexmedetomidine 1 mcg/kg body weight, Oral Diazepam 0.2 mg/kg body weight. Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Patients with ASA physical status I, patients having Mallampati I and II, patients with body mass index (BMI) < 30 kg/m2.

Exclusion criteria

Exclusion criteria: Patients refusal to participate in the study.Known allergy or hypersensitive reaction to dexmedetomidine or diazepam. Patients suffering from significant cardiac disease e.g IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc. 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. Pregnant women; no reliable contraceptive measures in postmenopausal women. Patients taking antihypertensive drugs such as methyldopa, clonidine and other Î±2 receptor agonists. Patients having morbid obesity, obstructive sleep apnoea, suspected difficult airway. Patients having liver and kidney dysfunction. Patients having long-term use of sedatives and analgesics. Patients having Mallampati grades III and IV.

Design outcomes

Primary

Measure	Time frame
Sedation and preoperative reduction in anxiety. Heart Rate (variation of 10 beats/min) and Blood pressure variation to laryngoscopy and endotracheal intubation.Timepoint: Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation.	—

Secondary

Measure	Time frame
Any side effects including bradycardia and hypotension.Timepoint: during the whole study period.	—

Countries

India

Contacts

Public ContactARKA DAS

BANGUR INSTITUE OF NEUROSCIENCES

saikatneuro1972@gmail.com9831732443

Outcome results

None listed

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