Inhalational versus intravenously administered dexmedetomidine for blunting hemodynamic responses to laryngoscopy and intubation: a randomized double blind comparative study

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/10/058557

Lead Sponsor: MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL

Brief Summary: Dexmedetomidine is well known to attenuate the laryngoscopic response when administered intravenous, however its adverse effects have limited its use. Various studies have been done to study effectiveness of intranasal dexmedetomidine. however there has been no mention of the comparison of side effects between the two routes. Studies with nebulization with dexmedetomidine are limited.

The proposed study intends to use a different route of administration(nebulization) to determine its efficacy in attenuation of laryngoscopic response with lesser incidence of adverse effects.

A human clinical study only can provide insight in to such issues.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Elective surgeries under general anaesthesia Patients of either sex having age 18-55years Body weight 50 to 70 kgs American society of anaesthesiologists (ASA) physical status I â€“ II Patientâ€™s written and informed consent.

Exclusion Criteria

Patient refusal for the anaesthetic technique.
Patients having mouth opening < 3 Cms or predicted difficult airway.
Any bleeding disorder or patient on anticoagulants History of allergy to study drug Patient belonging to ASA CLASS III, IV & V Patients on any sedatives, antipsychotics, antidepressants, anxiolytics or anticonvulsants and betablockers.
Patient with any nasal pathology like nasal ulcer, nasal polyp, nasal septum deviation.
Patients with difficult airway like cervical spine instability, facial fractures, partially obstructing laryngeal lesions (e.g., papilloma), craniofacial abnormalities, and temporo mandibular joint ankylosis.
Patient coming for emergency surgery Pregnant patients H/O Covid infection during last 3 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study will be to compare intravenous dexmedetomidine with nebulised dexmedetomidine as premedication for attenuation of laryngoscopic and intubation response.	Vitals will be recorded on starting the study drugs and after every 5 minutes interval till the endotracheal tube is inserted. Also, vitals will be recorded immediately after intubation, 1,3 and 5 minutes after intubation thereafter every 5 minutes up to 30 minutes after insertion of endotracheal tube than at extubation.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome of the study will be to study and compare the sedation score and	to study and compare the complications encountered with the two routes

Trial Locations

Locations (1): MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL
🇮🇳
Jaipur, RAJASTHAN, India
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL
🇮🇳Jaipur, RAJASTHAN, India
Dr Rajkumar Kishorkumar Saraswat
Principal investigator
7069977268
raj.saraswat46@gmail.com