The effect of intranasal dexmedetomidine and lignocaine spray on the laryngoscopy response during intubation.

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/05/087140
• Lead Sponsor: Christian Medical College Fluid Research Fund

Brief Summary

Through this study we aim to compare the effect of preoperativeintranasal dexmedetomidine and lignocaine spray in attenuation of haemodynamicresponses to laryngoscopy for endotracheal intubation in patients undergoingelective surgeries. Patients planned for elective surgeries who are willing toparticipate and meets inclusion criteria will be enrolled for the study. Aninformed consent will be obtained from patients preoperatively using aninformation sheet. Participants of the study will be divided into two groups bycomputer generated block randomization. Group A will receive a 1mcg per kg ofintranasal dexmedetomidine with atomizing device of company MADNasal Intranasal Mucosal Atomization Device 30minutes prior to induction in holding bay. Group B will receive 1.5mg per kg of 10 percent lignocaine spray prior to induction onto the oropharyngeal mucosa withatomization device. Both groups will receive normal saline placebo at therespective time. All patients willhave standard ASA monitoring with peripheral intravenous access. Generalanaesthesia will be administered as per standard institutional protocols. Inductionwill be done with propofol 1 to 2mg per kg, Fentanyl 1 to 2mcg per kg and titrated toeffect to maintain haemodynamics, Atracurium 0.5mg per kg.  Anaesthesia will be maintained with a MACof 0.7 to 0.8 of isoflurane. Unanticipated difficultairway, Intubation time, number of attempts, haemodynamic response to scopy  as Heart rate and Blood Pressure at baseline, 2 ,5 and 10 min post trachealintubation to be noted. Any bradycardia, hypotension, tachycardia orhypertension greater than 20 percent will be treated as per standard guidelines. Incidence ofsore throat post surgery will be documented.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

Adults of age 18 and 60 years of ASA I and II undergoing elective surgery under general anaesthesia with oral endotracheal tube intubation.

Exclusion Criteria

Patient refusal Allergy to either dexmedetomidine or lignocaine ASA III and IV Anticipated difficult airway Severe upper respiratory tract infection Known cardiac disease or liver disease BMI greater than 30kg per m2 Pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of intranasal dexmedetomidine and lignocaine spray on the laryngoscopy response in patients undergoing elective surgeries	baseline , 2 minute, 5 minutes, 10 minutes post tracheal intubation. Heart rate and Blood pressure will be measured

Secondary Outcome Measures

Name	Time	Method
Incidence of sore throat in patients post endotracheal intubation	more than 6 hours to less than 10 hours post surgery

Trial Locations

Locations (1)

Christian Medical College Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College Vellore

🇮🇳Vellore, TAMIL NADU, India

Raichel Kurian

Principal investigator

8547726721

kurian.raichel@gmail.com