Comparison of two different doses of a drug for better comfort of patient during procedure to insert a tube inside their air passage

Completed

• Conditions: Patients with oral cavity cancer

• Registration Number: CTRI/2018/04/013244
• Lead Sponsor: Ashish Walian

Brief Summary

A prospective randomised double blinded study was undertaken in patients with anticipated difficult intubation. Two groups were taken Group A patient were given Dexmedetomidine iv infusion 1mcg/kg over 10min and Group B patients were given Dexmedetomidine iv infusion 1.5mcg/kg over 10min prior performing retrograde intubation and groups were compared in terms of haemodynamic parameters and patient comfort during the procedure. Patients hemodynamic parameters in terms of heart rate and blood pressure were significantly higher in group A as compared to group B and patients of group B were better sedated during the retrograde intubation as compared to grouqp A patients. In terms of secondary outcome patientsfrom group B demonstrated better results in terms of patient reaction to intubation  cough severity, recall of procedure , discomfort during the procedure and use of ketofolas rescue therapy during the procedure as compared to group A. however in terms of ease of intubation, tolerance to endotracheal tube, intubating time and complications no significant difference was found between the two groups. In conclusion dexmedetomidine in a dose 1.5mcg/kg provide better intubating condition, hemodynamic stability, adequate sedation and patient comfort during retrograde intubation.

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-08-31
• Study Start: 2017-10-04
• Last Update Posted: 2018-03-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1- ASA class 1 and 2 patients 2- Mouth opening less then 2cm due to any pathology 3- MPG grade 3 and 4 4- Thyromental distance less then 4cm 5- Restricted cervical mobility due to bone and joint disorder.

Exclusion Criteria

1- Patient not giving consent to participate in the study 2- Patient with nasal mass 3- Patient with hypersensitivity to drug under study 4- Patients with history of ischemic heart disease 5- Patients with baseline heart rate less then 50bpm 6- morbidly obese patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Heart rate	Vitals were recorded every minute for 10min during dexmedetomidine infusion and at 0min 1min 5min 10min 15min during the intubation
2 Systolic blood pressure	Vitals were recorded every minute for 10min during dexmedetomidine infusion and at 0min 1min 5min 10min 15min during the intubation
3 Diastolic blood pressure	Vitals were recorded every minute for 10min during dexmedetomidine infusion and at 0min 1min 5min 10min 15min during the intubation
4 Oxygen saturation	Vitals were recorded every minute for 10min during dexmedetomidine infusion and at 0min 1min 5min 10min 15min during the intubation
5 Observer assessment of sedation score	Vitals were recorded every minute for 10min during dexmedetomidine infusion and at 0min 1min 5min 10min 15min during the intubation

Secondary Outcome Measures

Name	Time	Method
1 Ease of intubation	2 Patient reaction to placement of guidewire and tracheal tube

Trial Locations

Locations (1)

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

King Georges Medical University

🇮🇳Lucknow, UTTAR PRADESH, India

Ashish Walian

Principal investigator

9411687061

walian.ashish10@gmail.com